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Title: #53: Clinical Statistics for Nonstatisticians
Event Type: TUTORIAL
Credits: ACPE, CME, IACET
Tracks: Track 01 - Clinical Operations
Day: Sunday, Jun, 23
Time: 9:00AM - 5:00PM
Title: #40: Investigative Site Boot Camp: Innovative Solutions to your Operational Challenges
Event Type: TUTORIAL
Credits: CME, IACET
Tracks: Track 01 - Clinical Operations
Day: Sunday, Jun, 23
Time: 1:00PM - 6:00PM
Title: Shape Your Cost with Hard and Soft Coverage Analysis Trends
Event Type: WORKSHOP
Credits: CME, IACET, PMI, RN
Tracks: Track 01 - Clinical Operations
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: Trials, Studies and Programs: Diverse Operational Approaches to Generating Evidence in the Late-phase Environment
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: How Can Translational Medicine Fill the Gaps in Life Sciences Industries?
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 19 - Communities Showcase;Track 01 - Clinical Operations
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: Next Generation Medical Information Call Center
Event Type: SESSION
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison;Track 16 - Professional Development;Track 01 - Clinical Operations;Track 22 - White Paper Showcase
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: IntraLinks Innovation Theater: Crossing the Threshold – Clinical Portals from a Site Perspective
Event Type: SPECSESS
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 01 - Clinical Operations;Track 23 - Innovation Theater
Day: Monday, Jun, 24
Time: 1:00PM - 1:45PM
Title: Implementing Performance Metrics: How Investigator Sites Can Pave the Way for Running Successful Clinical Trials
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: Global Clinical Trials: The Role of Emerging Markets
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: Defining Clinical Trial Innovation: Challenges and Opportunities for 2013
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 19 - Communities Showcase;Track 01 - Clinical Operations
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: Leveraging In-Pharmacy Education to Improve Patient Comprehension and Access to Clinical Trials
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Is This Trial Worth It? A Panel Discussion for Sites and Project Managers
Event Type: SESSION
Credits: CME, IACET, PMI, RN
Tracks: Track 01 - Clinical Operations
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Moving to a Standards-based, Agile Clinical Development Lifecycle
Event Type: SESSION
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 07 - Processes and Technologies for Clinical Research;Track 01 - Clinical Operations;Track 22 - White Paper Showcase
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Deloitte Innovation Theater: Race for Real World Data - Outcomes Data and Analytics: Uses, Approach and Issues
Event Type: SPECSESS
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA);Track 07 - Processes and Technologies for Clinical Research;Track 01 - Clinical Operations;Track 23 - Innovation Theater
Day: Tuesday, Jun, 25
Time: 9:40AM - 10:10AM
Title: Optimizing Trial Feasibility by Leveraging Electronic Health Record (EHR) Data and Engaging Investigators and Patient Advocacy Groups
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: Domestic and Global Trends in Clinical Trial Budgeting
Event Type: WORKSHOP
Credits: CME, IACET, PMI, RN
Tracks: Track 01 - Clinical Operations
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: Circulating Tumor Cells (CTCs) as a Biomarker Approach in Oncology
Event Type: SESSION
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 08 - Regulatory Affairs and Submissions;Track 01 - Clinical Operations;Track 22 - White Paper Showcase
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: Big Data: Impact on Innovation
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) ;Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA);Track 15 - Statistical Science and Quantitative Thinking;Track 07 - Processes and Technologies for Clinical Research;Track 14 - Clinical Safety and Pharmacovigilance;Track 01 - Clinical Operations
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: Enrollment Analytics: Moving Beyond the Funnel
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Taking the Measure of Metrics
Event Type: SYMPOSIUM
Credits: CME, IACET, PMI, RN
Tracks: Track 01 - Clinical Operations
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Learning to Share-Sharing To Learn: How an Industry Learns to Honor Its Volunteers
Event Type: SESSION
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 08 - Regulatory Affairs and Submissions;Track 16 - Professional Development;Track 01 - Clinical Operations;Track 22 - White Paper Showcase
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Reinventing the R&D Business Model: Heeding the President's PCAST Report on Innovation
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 20 - Executive Program;Track 01 - Clinical Operations
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: INC Research Innovation Theater: Innovating Clinical Development Through Data-driven Operational Strategy
Event Type: SPECSESS
Tracks: Track 07 - Processes and Technologies for Clinical Research;Track 01 - Clinical Operations;Track 23 - Innovation Theater
Day: Tuesday, Jun, 25
Time: 3:25PM - 3:55PM
Title: Approaches to Risk-based Monitoring
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: Evaluating Sites for Optimum Site Selection and Performance
Event Type: SESSION
Credits: CME, IACET, PMI, RN
Tracks: Track 01 - Clinical Operations
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: Four Ways to Accelerate Clinical Portfolio Strategy
Event Type: SESSION
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 08 - Regulatory Affairs and Submissions;Track 02 - Project/Portfolio Management and Strategic Planning;Track 01 - Clinical Operations;Track 22 - White Paper Showcase
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: Where Research, Medicine and Care Converge: A CMO Roundtable Discussion
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 20 - Executive Program;Track 01 - Clinical Operations
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: Clinical Trial Design for Optimal Patient Recruitment and Retention
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Understanding Operational Feasibility: A Discussion of Current Methodologies, Primary Research Limitations and Opportunities
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Collaborating to Streamline Drug Development: Are We Making Progress?
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 08 - Regulatory Affairs and Submissions;Track 01 - Clinical Operations;Track 21 - Late Breaker
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: FDA-Health Canada Regulatory Cooperation Council (RCC) Town Hall
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 14 - Clinical Safety and Pharmacovigilance;Track 18 - Global Regulatory;Track 01 - Clinical Operations
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Study Startup Symposium
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Wednesday, Jun, 26
Time: 10:15AM - 11:45AM
Title: Meeting the Operational Challenges of Risk-based Monitoring: Investigator and Sponsor Perspectives
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Wednesday, Jun, 26
Time: 10:15AM - 11:45AM
Title: Driven by Data: More Effective Strategies to Reach Your Patient Recruitment Goals
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Wednesday, Jun, 26
Time: 10:15AM - 11:45AM
Title: Advancing Alzheimer’s Innovation: A Call to Action
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 08 - Regulatory Affairs and Submissions;Track 10 - Public Policy/ Health Care Compliance/ Law;Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) ;Track 16 - Professional Development;Track 17 - Rare/Orphan Diseases;Track 07 - Processes and Technologies for Clinical Research;Track 14 - Clinical Safety and Pharmacovigilance;Track 01 - Clinical Operations
Day: Wednesday, Jun, 26
Time: 10:15AM - 11:45AM
Title: Using Big Data to Design Smarter Studies
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Advancing Alzheimer's Innovation: Patient Advocacy, Caregiver Support and Health Care System Impact
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 01 - Clinical Operations
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Innovative Ways of Working with Patients to Make Clinical Research More Productive, Less Costly and Less Burdensome for the Patient
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Overcoming Unique Challenges of Pediatric Studies
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: TransCelerate’s Collaborative Approach for Site Qualification and Training Efficiencies
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) ;Track 01 - Clinical Operations;Track 21 - Late Breaker
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Parents as Partners: Engaging Caregivers for Pediatric Trials
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Thursday, Jun, 27
Time: 9:00AM - 10:30AM
Title: Hot Topics in Clinical Supplies
Event Type: SYMPOSIUM
Credits: IACET
Tracks: Track 01 - Clinical Operations
Day: Thursday, Jun, 27
Time: 9:00AM - 10:30AM
Title: Impact and Interventions Related to FDASIA: Increasing Diversity in Clinical Trials
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Thursday, Jun, 27
Time: 10:45AM - 12:15PM
Title: CRA’s Knowledge and Adaptability Required to Monitor Informed Consent Process in an Evolving Regulatory Environment
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Thursday, Jun, 27
Time: 10:45AM - 12:15PM

Title: Stage Gate Decision-making Workshop, Part 1 of 2
Event Type: WORKSHOP
Credits: CME, IACET, RN
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: Portfolio Management Symposium
Event Type: SYMPOSIUM
Credits: IACET, PMI
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: Stage Gate Decision-making Workshop, Part 2 of 2
Event Type: WORKSHOP
Credits: CME, IACET, RN
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: Bridging the Gap Between Strategy and Execution
Event Type: SYMPOSIUM
Credits: CME, IACET, PMI, RN
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: The Financial, Resource and Planning Challenges of Incorporation of Mandatory Language into Protocols
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Careers Beyond Project and Portfolio Management: A Panel Discussion
Event Type: FORUM
Credits: IACET, PMI
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Effective Diverse Team Collaboration and Management for Drug Development: Key Commonalities and Differences among Korea, China and Japan
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: Regulatory, Clinical, and Quality Challenges in Contracting and Due Diligence: The Forgotten Keys to Biopharma Transactions
Event Type: SESSION
Credits: ACPE, IACET
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Approaches to Quality Risk Management: Understanding What Matters
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Strategic Planning of the Global Program to Facilitate Regulatory Approval and Market Access
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: Four Ways to Accelerate Clinical Portfolio Strategy
Event Type: SESSION
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 08 - Regulatory Affairs and Submissions;Track 02 - Project/Portfolio Management and Strategic Planning;Track 01 - Clinical Operations;Track 22 - White Paper Showcase
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: Cost Management for Global Drug Development Projects
Event Type: SESSION
Credits: CME, IACET, PMI, RN
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Stop Moving the Goalposts: A Life Cycle Approach to Risk-based Quality Management in Clinical Development
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: So You Want to Be a Project Manager: How to Find Your Way to a Challenging and Rewarding Career
Event Type: FORUM
Credits: IACET
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Wednesday, Jun, 26
Time: 10:15AM - 11:45AM
Title: Challenges and Strategic Approaches to Biosimilar Development
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Using Competence Models to Drive High Quality Drug Project Management
Event Type: SESSION
Credits: CME, IACET, PMI, RN
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Pharmacometric Methods: Essential for Optimal Drug Development Strategy
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Pharmaceutical Project Management: What's Really Important and How Can We Do Better?
Event Type: SESSION
Credits: IACET, PMI
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Advancing Alzheimer’s Innovation: Clinical Development Successes and Challenges
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 08 - Regulatory Affairs and Submissions;Track 02 - Project/Portfolio Management and Strategic Planning
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Orphan Drug Development Strategy by Big and Medium/Small Pharmaceutical Industries
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Thursday, Jun, 27
Time: 9:00AM - 10:30AM
Title: The Importance of Country Selection in Clinical Study Design
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Thursday, Jun, 27
Time: 10:45AM - 12:15PM

Title: #51: Quality Oversight of CROs-Clinical Vendors
Event Type: TUTORIAL
Credits: IACET
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Sunday, Jun, 23
Time: 9:00AM - 5:00PM
Title: The State of Clinical Outsourcing: Managing Risk in Outsourced Clinical Trials
Event Type: FORUM
Credits: CME, IACET, PMI, RN
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: Innovative Partnerships for mHealth
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Monday, Jun, 24
Time: 11:00AM - 12:15PM
Title: IntraLinks Innovation Theater: Crossing the Threshold – Clinical Portals from a Site Perspective
Event Type: SPECSESS
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 01 - Clinical Operations;Track 23 - Innovation Theater
Day: Monday, Jun, 24
Time: 1:00PM - 1:45PM
Title: Implementing Regulatory Outsourcing Partnerships: New Trends and Practices
Event Type: FORUM
Credits: IACET
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: Making CRO-Sponsor Partnerships Work: Executive Roundtable
Event Type: FORUM
Credits: IACET, PMI
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Developing and Maintaining Sponsor/CRO Partnership Regulatory Submissions Processes: Challenges and Successes
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: Change Order Panel Discussion and Brainstorming Session: Can We Be More Efficient?
Event Type: FORUM
Credits: CME, IACET, PMI, RN
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: Pharma, Academia and CRO Preferred Partnerships: Why Collaboration Makes a Better Global Trial
Event Type: FORUM
Credits: CME, IACET, PMI, RN
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: FDA Collaborations Broaden the Reach of Health Care Messages to Effectively Communicate with the Public
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Learning to Share-Sharing To Learn: How an Industry Learns to Honor Its Volunteers
Event Type: SESSION
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 08 - Regulatory Affairs and Submissions;Track 16 - Professional Development;Track 01 - Clinical Operations;Track 22 - White Paper Showcase
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Investigator Budgets Impact on Patient Enrollment and Retention: How to Improve Sponsor/CRO/Site Processes to Increase Productivity
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: Four Ways to Accelerate Clinical Portfolio Strategy
Event Type: SESSION
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 08 - Regulatory Affairs and Submissions;Track 02 - Project/Portfolio Management and Strategic Planning;Track 01 - Clinical Operations;Track 22 - White Paper Showcase
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: Evolving to Functional Service Providers (FSP): Successfully Transforming Existing Partnerships into FSP Relationships
Event Type: FORUM
Credits: IACET
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Unique Nonprofit-Industry Partnerships to Develop and Disseminate Technology
Event Type: SESSION
Credits: IACET
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Collaborating to Streamline Drug Development: Are We Making Progress?
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 08 - Regulatory Affairs and Submissions;Track 01 - Clinical Operations;Track 21 - Late Breaker
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Project Data Sphere: Clinical Trial Data-sharing in Cancer to Accelerate Innovation and Enhance Patient Health
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Wednesday, Jun, 26
Time: 10:15AM - 11:45AM
Title: Innovative Strategies for Evolving Sponsor, CRO and Site Alliances
Event Type: SESSION
Credits: IACET, PMI
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Wednesday, Jun, 26
Time: 10:15AM - 11:45AM
Title: Towards an Effective Virtual R&D Team for Faster Accessing of the East Asian Market
Event Type: SESSION
Credits: CME, IACET, PMI, RN
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Clinical Outcome Assessment for Clinical Trials: PROs, ClinROs, and ObsROs
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 08 - Regulatory Affairs and Submissions;Track 19 - Communities Showcase
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Partnering and Outsourcing Challenges in India: The New Paradigm Shifts
Event Type: SYMPOSIUM
Credits: CME, IACET, PMI, RN
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Strategic Partnerships: Emerging Models and Their Impact on Drug Development
Event Type: FORUM
Credits: CME, IACET, PMI, RN
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Thursday, Jun, 27
Time: 9:00AM - 10:30AM
Title: Transforming Relationships to Adapt to Evolving Organizational Strategic Goals
Event Type: SESSION
Credits: CME, IACET, PMI, RN
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Thursday, Jun, 27
Time: 10:45AM - 12:15PM

Title: Global Symposium
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: How Can Translational Medicine Fill the Gaps in Life Sciences Industries?
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 19 - Communities Showcase;Track 01 - Clinical Operations
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: Translational Aspects from Preclinical Animal Toxicology Studies to Early Human Health Risk Assessment: Needs and Limitations
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: The Thorough QT Study: Isn’t There a Better Way to Do This?
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Measuring the Impact of Subject Dual Enrollment on Study Data Validity and a Web-based Tool to Avoid Simultaneous Participation in Multiple Concurrent Clinical Trials
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: Circulating Tumor Cells (CTCs) as a Biomarker Approach in Oncology
Event Type: SESSION
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 08 - Regulatory Affairs and Submissions;Track 01 - Clinical Operations;Track 22 - White Paper Showcase
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: Human Abuse Liability Testing in CNS Drug Development
Event Type: WORKSHOP
Credits: ACPE, CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: First-in-Human Studies: How Much Complexity Is Too Much?
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 19 - Communities Showcase
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Optimizing the Transition from Preclinical to Clinical Research
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: Molecular Imaging: Utilizing It as an Effective Drug Development Tool
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Pharmacometrics: Implications and Impact in Preclinical to Early Phase Clinical Development
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development
Day: Wednesday, Jun, 26
Time: 10:15AM - 11:45AM
Title: Advancing Alzheimer’s Innovation: A Call to Action
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 08 - Regulatory Affairs and Submissions;Track 10 - Public Policy/ Health Care Compliance/ Law;Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) ;Track 16 - Professional Development;Track 17 - Rare/Orphan Diseases;Track 07 - Processes and Technologies for Clinical Research;Track 14 - Clinical Safety and Pharmacovigilance;Track 01 - Clinical Operations
Day: Wednesday, Jun, 26
Time: 10:15AM - 11:45AM
Title: Advancing Alzheimer’s Innovation: Clinical Development Successes and Challenges
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 08 - Regulatory Affairs and Submissions;Track 02 - Project/Portfolio Management and Strategic Planning
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM

Title: Prescription Drug Marketing Regulatory Primer
Event Type: WORKSHOP
Credits: ACPE, CME, IACET, RN
Tracks: Track 05 - Regulation of Product Advertising and Marketing in an Ever-changing World
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: FDA Enforcement Update: Advertising and Promotion
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 05 - Regulation of Product Advertising and Marketing in an Ever-changing World
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: Drug Development for Commercial Success
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 05 - Regulation of Product Advertising and Marketing in an Ever-changing World
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Product Communications in the Preapproval Phase
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 05 - Regulation of Product Advertising and Marketing in an Ever-changing World
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM

Title: #54: Art of Writing a Clinical Overview
Event Type: TUTORIAL
Credits: IACET
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison
Day: Sunday, Jun, 23
Time: 9:00AM - 5:00PM
Title: #41: The DIA - HBA Skill Building Series: A Custom-Fit Leadership Approach for Women in the Regulatory, Medical, Legal and Compliance Functions
Event Type: TUTORIAL
Credits: IACET
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison;Track 08 - Regulatory Affairs and Submissions;Track 10 - Public Policy/ Health Care Compliance/ Law
Day: Sunday, Jun, 23
Time: 1:00PM - 6:00PM
Title: Finessing Scientifically Accurate, Comprehensible, Compliant, Clinically-focused Module 2 Summaries of an eCTD-based Submission
Event Type: FORUM
Credits: IACET
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: Next Generation Medical Information Call Center
Event Type: SESSION
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison;Track 16 - Professional Development;Track 01 - Clinical Operations;Track 22 - White Paper Showcase
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: The Regulatory Writing Game Show
Event Type: WORKSHOP
Credits: IACET
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Innovation and Evolution Within the Medical Science Liaison Role
Event Type: SYMPOSIUM
Credits: IACET
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Preparation of Clinical Study Reports and Summary Documents: Maximize Efficiency and Minimize Redundancy
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: The New European Pharmacovigilance Legislation: Guiding Medical Writers Through the Risks and Benefits
Event Type: SESSION
Credits: IACET
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Protocol Trends and Strategies for Quality
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: Tethering the Channels of Scientific and Medical Content
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Bringing SPIRIT into Protocols, Structuring Content and Expanding This Work to Noninterventional Postmarketing Protocols
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison;Track 19 - Communities Showcase
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Globalization of Medical Communications/Medical Science Liaisons: A Comparison of Guidance and Practice Differences
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison
Day: Wednesday, Jun, 26
Time: 10:15AM - 11:45AM
Title: Recent Corporate Integrity Agreements: Impact on Industry-sponsored Publications and Medical Communications Activities
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Learnings from Safety Communications Across the Industry: Patients and EMA, REMS and FDA, Physicians and Medical Information Groups
Event Type: SYMPOSIUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Current Regulatory Landscape Impacting Medical and Scientific Communications
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison;Track 19 - Communities Showcase
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Key Learnings from the Approval and Launch of a 505(b)(2) Product from a Medical Communications Perspective
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison
Day: Thursday, Jun, 27
Time: 9:00AM - 10:30AM
Title: Insights into China: Practical Tips for Writing Publication and Regulatory Documents
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison
Day: Thursday, Jun, 27
Time: 10:45AM - 12:15PM

Title: Evaluation and Selection of the Optimal Endpoints for Clinical Studies
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: Managing Data at Arms' Length: China
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: CDISC SHARE: A Promising Approach to Therapeutic Area Standards Development
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: That Awkward Stage: Transition from Paper Trial Master File to eTMF
Event Type: SESSION
Credits: IACET
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: Data from Everyone: Using Smartphones and the Internet to Connect with Subjects
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Development of a New Patient-reported Outcome (PRO) Measure for Depression: Progress and Results from the PRO Consortium
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Moving to a Standards-based, Agile Clinical Development Lifecycle
Event Type: SESSION
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 07 - Processes and Technologies for Clinical Research;Track 01 - Clinical Operations;Track 22 - White Paper Showcase
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Deloitte Innovation Theater: Race for Real World Data - Outcomes Data and Analytics: Uses, Approach and Issues
Event Type: SPECSESS
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA);Track 07 - Processes and Technologies for Clinical Research;Track 01 - Clinical Operations;Track 23 - Innovation Theater
Day: Tuesday, Jun, 25
Time: 9:40AM - 10:10AM
Title: Achieving Innovative Technology Results
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research;Track 19 - Communities Showcase
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: Big Data: Impact on Innovation
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) ;Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA);Track 15 - Statistical Science and Quantitative Thinking;Track 07 - Processes and Technologies for Clinical Research;Track 14 - Clinical Safety and Pharmacovigilance;Track 01 - Clinical Operations
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: Cambridge Semantics Innovation Theater: How Can Technology Change the Way Pharmas Handle Risk? Innovations in Drug Safety and Business Development
Event Type: SPECSESS
Tracks: Track 07 - Processes and Technologies for Clinical Research;Track 14 - Clinical Safety and Pharmacovigilance;Track 23 - Innovation Theater
Day: Tuesday, Jun, 25
Time: 12:15PM - 1:00PM
Title: Changing View of Electronic Data Capture (EDC) and Implications for Data Quality
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Innovative Computerized System Validation and Auditing
Event Type: FORUM
Credits: CME, IACET, PMI, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: INC Research Innovation Theater: Innovating Clinical Development Through Data-driven Operational Strategy
Event Type: SPECSESS
Tracks: Track 07 - Processes and Technologies for Clinical Research;Track 01 - Clinical Operations;Track 23 - Innovation Theater
Day: Tuesday, Jun, 25
Time: 3:25PM - 3:55PM
Title: Real-world Electronic Health Records Data and Informatics Technology in Drug Development and Life Cycle Management
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: Real, Transparent Dialogue from Three Sponsors: Destination eTMF - Are We There Yet?
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: Challenges and Recommendations Related to the Use of ePRO Instruments in Clinical Trials
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Enhancing Regulatory Science and Expediting Drug Development: eClinical and eHealth Tools
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Advancing Alzheimer’s Innovation: A Call to Action
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 08 - Regulatory Affairs and Submissions;Track 10 - Public Policy/ Health Care Compliance/ Law;Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) ;Track 16 - Professional Development;Track 17 - Rare/Orphan Diseases;Track 07 - Processes and Technologies for Clinical Research;Track 14 - Clinical Safety and Pharmacovigilance;Track 01 - Clinical Operations
Day: Wednesday, Jun, 26
Time: 10:15AM - 11:45AM
Title: EDC Insights: Before, During, and After
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Wednesday, Jun, 26
Time: 10:15AM - 11:45AM
Title: Advancing Endpoint Adjudication
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Wednesday, Jun, 26
Time: 10:15AM - 11:45AM
Title: SAS Innovation Theater: Picture This: Bringing Clinical Data to Life
Event Type: SPECSESS
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA);Track 07 - Processes and Technologies for Clinical Research;Track 14 - Clinical Safety and Pharmacovigilance;Track 23 - Innovation Theater
Day: Wednesday, Jun, 26
Time: 12:15PM - 1:00PM
Title: Cloud Technology for Decision Makers: What’s Real and How to Validate It
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Coalition for Accelerating Standards and Therapies (CFAST): The Ultimate Drug Development Drivers
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Clinical Trial Visit of the Future: Leveraging Emerging Technologies to Crack the Patient Recruitment Challenge
Event Type: WORKSHOP
Credits: CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Data Standards Strategy
Event Type: SESSION
Credits: CME, IACET, PMI, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: eDM From Three Sponsors
Event Type: SESSION
Credits: IACET
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Thursday, Jun, 27
Time: 9:00AM - 10:30AM
Title: Changing Landscape of IT in the Pharmaceutical Industry
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Thursday, Jun, 27
Time: 9:00AM - 10:30AM
Title: Emerging Electronic Tools in Cardiovascular Outcomes Studies
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Thursday, Jun, 27
Time: 10:45AM - 12:15PM
Title: Implementing a Paperless Trial for Phase 3: A Biotech’s Lessons Learned
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Thursday, Jun, 27
Time: 10:45AM - 12:15PM
Title: What's the Point? Can Point of Care Devices Enhance Clinical Trials?
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Thursday, Jun, 27
Time: 10:45AM - 12:15PM

Title: #20: Japan's Regulatory Environment: Overview of the Organization, Processes, Systems and Changes Affecting Pharmaceutical Development
Event Type: TUTORIAL
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Sunday, Jun, 23
Time: 8:30AM - 12:00PM
Title: #21: FDA Enforcement: Understanding the Agency's Authority, How Violations Occur, How to Prevent Them and How to Respond if Violations Do Occur
Event Type: TUTORIAL
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Sunday, Jun, 23
Time: 8:30AM - 12:00PM
Title: #50: Understanding and Navigating the Regulatory System in China
Event Type: TUTORIAL
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Sunday, Jun, 23
Time: 9:00AM - 5:00PM
Title: #52: Regulatory Affairs for Biologics
Event Type: TUTORIAL
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Sunday, Jun, 23
Time: 9:00AM - 5:00PM
Title: #57: Preparing for a US FDA Advisory Committee Meeting
Event Type: TUTORIAL
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Sunday, Jun, 23
Time: 9:00AM - 3:45PM
Title: #41: The DIA - HBA Skill Building Series: A Custom-Fit Leadership Approach for Women in the Regulatory, Medical, Legal and Compliance Functions
Event Type: TUTORIAL
Credits: IACET
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison;Track 08 - Regulatory Affairs and Submissions;Track 10 - Public Policy/ Health Care Compliance/ Law
Day: Sunday, Jun, 23
Time: 1:00PM - 6:00PM
Title: #32: Understanding Translational Medicine: Benefits and Innovative Approaches
Event Type: TUTORIAL
Credits: CME, IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Sunday, Jun, 23
Time: 1:00PM - 4:30PM
Title: #34: Fourteen Steps from Research to Development
Event Type: TUTORIAL
Credits: CME, IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Sunday, Jun, 23
Time: 1:00PM - 4:30PM
Title: #35: Successful Drug Development: Best Practices for Clinical Trial Design, Agency Interactions and Regulatory Document Writing
Event Type: TUTORIAL
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Sunday, Jun, 23
Time: 1:00PM - 4:30PM
Title: Is There a Disagreement? We Can Help - Dispute Resolution between Industry and US/EU Regulators
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: Pediatric Drug Development: A New Paradigm Under FDASIA
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: Navigating the Regulatory Pathway for Advanced Therapy Medicinal Products (ATMPs) and Combined ATMPs
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: Cooperation Among Regulators: Impact on Stakeholders
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 10 - Public Policy/ Health Care Compliance/ Law;Track 18 - Global Regulatory
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: Roundtable on Personalized Therapy Innovation in Rare Disease: Focus on Public Policy
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 17 - Rare/Orphan Diseases
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: A Regulatory Perspective of Biosimilars in Emerging Markets
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Expediting Drug Development and Review for Serious Conditions
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Moving to a Standards-based, Agile Clinical Development Lifecycle
Event Type: SESSION
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 07 - Processes and Technologies for Clinical Research;Track 01 - Clinical Operations;Track 22 - White Paper Showcase
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Circulating Tumor Cells (CTCs) as a Biomarker Approach in Oncology
Event Type: SESSION
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 08 - Regulatory Affairs and Submissions;Track 01 - Clinical Operations;Track 22 - White Paper Showcase
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: The Aging Population: Approaches to Ensure Safety and Efficacy
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: Big Data: Impact on Innovation
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) ;Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA);Track 15 - Statistical Science and Quantitative Thinking;Track 07 - Processes and Technologies for Clinical Research;Track 14 - Clinical Safety and Pharmacovigilance;Track 01 - Clinical Operations
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: Learning to Share-Sharing To Learn: How an Industry Learns to Honor Its Volunteers
Event Type: SESSION
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 08 - Regulatory Affairs and Submissions;Track 16 - Professional Development;Track 01 - Clinical Operations;Track 22 - White Paper Showcase
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: US and EU Regulatory Update of Clinical Trial Disclosure
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Electronic Submissions in PDUFA V
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Implementing an Internationally Acceptable Framework for the Benefit-risk Assessment of Medicines: How Close Are We to This?
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Co-development of Targeted Therapies and Companion Diagnostics: Identifying Regulatory Strategies to Overcome Challenges
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Reinventing the R&D Business Model: Heeding the President's PCAST Report on Innovation
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 20 - Executive Program;Track 01 - Clinical Operations
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Four Ways to Accelerate Clinical Portfolio Strategy
Event Type: SESSION
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 08 - Regulatory Affairs and Submissions;Track 02 - Project/Portfolio Management and Strategic Planning;Track 01 - Clinical Operations;Track 22 - White Paper Showcase
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: Labeling and Patient Medical Information (PMI)
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: Bringing the Views of “Payer Regulators” into Product Development to Align Label Outcomes and Safety with Patient Access
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: The Evolving Clinical Trial Disclosure Global Landscape
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 19 - Communities Showcase
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: Where Research, Medicine and Care Converge: A CMO Roundtable Discussion
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 20 - Executive Program;Track 01 - Clinical Operations
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: Collaborating to Streamline Drug Development: Are We Making Progress?
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 08 - Regulatory Affairs and Submissions;Track 01 - Clinical Operations;Track 21 - Late Breaker
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Regulatory Operations: Types and Industry Trends of Outsourcing the Life Cycle Management of Your Electronic Submissions
Event Type: SESSION
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: FDASIA: Impact of New Legislative Provisions on Innovative Drug Development
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: How to Prepare for Meetings, Both Internal and with the FDA
Event Type: WORKSHOP
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 12 - Pharmaceutical Quality
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: FDA-Health Canada Regulatory Cooperation Council (RCC) Town Hall
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 14 - Clinical Safety and Pharmacovigilance;Track 18 - Global Regulatory;Track 01 - Clinical Operations
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Advancing Alzheimer’s Innovation: A Call to Action
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 08 - Regulatory Affairs and Submissions;Track 10 - Public Policy/ Health Care Compliance/ Law;Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) ;Track 16 - Professional Development;Track 17 - Rare/Orphan Diseases;Track 07 - Processes and Technologies for Clinical Research;Track 14 - Clinical Safety and Pharmacovigilance;Track 01 - Clinical Operations
Day: Wednesday, Jun, 26
Time: 10:15AM - 11:45AM
Title: A Comparison of Study Startup Regulations and Timelines in Several Major Emerging Markets and the Decision Process for Selection
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Wednesday, Jun, 26
Time: 10:15AM - 11:45AM
Title: Clinical Outcome Assessment for Clinical Trials: PROs, ClinROs, and ObsROs
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 08 - Regulatory Affairs and Submissions;Track 19 - Communities Showcase
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: FDASIA Patient Provisions: One Year Later
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: eSubmission Outsourcing and Mergers and Acquisitions: Now This Is an Intriguing Equation
Event Type: SESSION
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Advancing Alzheimer's Innovation: Patient Advocacy, Caregiver Support and Health Care System Impact
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 01 - Clinical Operations
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: TransCelerate’s Collaborative Approach to Risk-based Monitoring: The Methodology
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 12 - Pharmaceutical Quality;Track 14 - Clinical Safety and Pharmacovigilance;Track 21 - Late Breaker
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Advancing Alzheimer’s Innovation: Clinical Development Successes and Challenges
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 08 - Regulatory Affairs and Submissions;Track 02 - Project/Portfolio Management and Strategic Planning
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Global Pediatric Development: Next Steps
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Electronic Regulatory Submission (ERS) Development and the Impact on the Sponsor’s Organization: Retooling R&D for ERS
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Challenges for Stable Supply of Drugs and International Cooperation
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 12 - Pharmaceutical Quality;Track 18 - Global Regulatory
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: NDA Submission Strategy for New Chemical Entity (NCE) Products in Asia Pacific Countries to Reduce Drug Lag
Event Type: WORKSHOP
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Thursday, Jun, 27
Time: 9:00AM - 10:30AM
Title: Certificate of Pharmaceutical Product (CPPs): How Can the Process for Obtaining from and Submitting to Health Authorities Be Made More Efficient? Moving from Ribbons and Wax to Electronic Solutions
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Thursday, Jun, 27
Time: 10:45AM - 12:15PM

Title: #23: A Device Primer: 510(k)s, PMAs, IDEs
Event Type: TUTORIAL
Credits: CME, IACET
Tracks: Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products
Day: Sunday, Jun, 23
Time: 8:30AM - 12:00PM
Title: Regulatory Environment in the US: CDRH Panel Discusses What's on the Horizon
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products;Track 18 - Global Regulatory
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: Update on Submission and GMP Expectations for Part 3 Combination Products
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products;Track 12 - Pharmaceutical Quality
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: Postmarket Surveillance Issues for Medical Devices
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Co-development of Targeted Therapies and Companion Diagnostics: Identifying Regulatory Strategies to Overcome Challenges
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Diagnostic Biomarker Verification and Validation: A Cost-efficient, Speed to Market Adaptive Design Clinical Trial Model
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: How to Convert a New Device (PMA) into an Old (510(k)) Device: The De Novo 510(k)
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Developing Effective Policy Strategies for Coverage and Reimbursement of Companion Diagnostics
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Global Development of Novel Combination Products: Regulatory and Clinical Case Studies from Biotech and Pharma Sponsors
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Medical Devices Global Symposium
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products
Day: Thursday, Jun, 27
Time: 9:00AM - 10:30AM

Title: #41: The DIA - HBA Skill Building Series: A Custom-Fit Leadership Approach for Women in the Regulatory, Medical, Legal and Compliance Functions
Event Type: TUTORIAL
Credits: IACET
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison;Track 08 - Regulatory Affairs and Submissions;Track 10 - Public Policy/ Health Care Compliance/ Law
Day: Sunday, Jun, 23
Time: 1:00PM - 6:00PM
Title: Clinical Trials on Trial: Potential Legal Liability Arising from Clinical Trials
Event Type: WORKSHOP
Credits: ACPE, CME, IACET, RN
Tracks: Track 10 - Public Policy/ Health Care Compliance/ Law
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: Cooperation Among Regulators: Impact on Stakeholders
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 10 - Public Policy/ Health Care Compliance/ Law;Track 18 - Global Regulatory
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: Legal Jeopardy from the Conduct of Clinical Trials
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 10 - Public Policy/ Health Care Compliance/ Law
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: Ethical Issues in Clinical Trials
Event Type: WORKSHOP
Credits: ACPE, CME, IACET, RN
Tracks: Track 10 - Public Policy/ Health Care Compliance/ Law
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Breakthrough Therapy: One Candle on the Birthday Cake - Are Innovators Enjoying Sweet Success or Is the Pathway Not Baked Yet?
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 10 - Public Policy/ Health Care Compliance/ Law
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: Using Legislation to Advance Regulatory Science: "I'm Just a Bill..."
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 10 - Public Policy/ Health Care Compliance/ Law
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Advancing Alzheimer’s Innovation: A Call to Action
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 08 - Regulatory Affairs and Submissions;Track 10 - Public Policy/ Health Care Compliance/ Law;Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) ;Track 16 - Professional Development;Track 17 - Rare/Orphan Diseases;Track 07 - Processes and Technologies for Clinical Research;Track 14 - Clinical Safety and Pharmacovigilance;Track 01 - Clinical Operations
Day: Wednesday, Jun, 26
Time: 10:15AM - 11:45AM
Title: Enforcement Trends and Public Policy: Lessons Learned and Practices to Follow
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 10 - Public Policy/ Health Care Compliance/ Law
Day: Wednesday, Jun, 26
Time: 10:15AM - 11:45AM
Title: The Science of Compliance
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 10 - Public Policy/ Health Care Compliance/ Law
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Meeting the Challenges of Health Care Disparities and Clinical Trial Requirements in the Global Environment
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 10 - Public Policy/ Health Care Compliance/ Law
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Ethical Issues in Clinical Trials
Event Type: WORKSHOP
Credits: ACPE, CME, IACET, RN
Tracks: Track 10 - Public Policy/ Health Care Compliance/ Law
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM

Title: Practical Considerations for GCP Audits in a Risk-based Environment
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: Vendor Management Using Quality by Design and Risk Management Strategies
Event Type: SESSION
Credits: IACET
Tracks: Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: Effectiveness Checks in the Clinical Research Setting
Event Type: WORKSHOP
Credits: CME, IACET, RN
Tracks: Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: Quality Risk Management: An Old Hat?
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: GCP and Inspection Readiness
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Using Risk-based Signal Detection Methods to Identify Sites with Potential GCP Problems: Better Than a Crystal Ball
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) ;Track 19 - Communities Showcase
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Big Data: Impact on Innovation
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) ;Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA);Track 15 - Statistical Science and Quantitative Thinking;Track 07 - Processes and Technologies for Clinical Research;Track 14 - Clinical Safety and Pharmacovigilance;Track 01 - Clinical Operations
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: GCP Risk-based Monitoring
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: GCPs in Emerging Countries
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: How Will Risk-adapted Clinical Trials Be Inspected?
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Advancing Alzheimer’s Innovation: A Call to Action
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 08 - Regulatory Affairs and Submissions;Track 10 - Public Policy/ Health Care Compliance/ Law;Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) ;Track 16 - Professional Development;Track 17 - Rare/Orphan Diseases;Track 07 - Processes and Technologies for Clinical Research;Track 14 - Clinical Safety and Pharmacovigilance;Track 01 - Clinical Operations
Day: Wednesday, Jun, 26
Time: 10:15AM - 11:45AM
Title: FDA/EMA/WHO Collaboration and Cooperation on Good Clinical Practice (GCP), Bioequivalence (BE) and Pharmacovigilance (PV) Inspections
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Innovations in Proactive Quality Management: Best Practices and Variability in Approaches to Proactive Quality Management
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: TransCelerate’s Collaborative Approach for Site Qualification and Training Efficiencies
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) ;Track 01 - Clinical Operations;Track 21 - Late Breaker
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: eSource Symposium
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
Day: Thursday, Jun, 27
Time: 9:00AM - 10:30AM
Title: Protocol Deviations: Avoidable Problems or an Unavoidable Risk
Event Type: WORKSHOP
Credits: CME, IACET, RN
Tracks: Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
Day: Thursday, Jun, 27
Time: 10:45AM - 12:15PM

Title: Chemistry, Manufacturing and Controls (CMC) Regulatory Landscape in Emerging Markets
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 12 - Pharmaceutical Quality
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: Update on Submission and GMP Expectations for Part 3 Combination Products
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products;Track 12 - Pharmaceutical Quality
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: Developing and Embracing a Culture of Quality in the Pharmaceutical Industry
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 12 - Pharmaceutical Quality
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Strategies for the Development and Registration of Antibody Drug Conjugates
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 12 - Pharmaceutical Quality
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: Lessons Learned from the EMA-FDA Quality by Design (QbD) Pilot
Event Type: SESSION
Credits: IACET
Tracks: Track 12 - Pharmaceutical Quality
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: How to Prepare for Meetings, Both Internal and with the FDA
Event Type: WORKSHOP
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 12 - Pharmaceutical Quality
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Current Developments in the Automated NDA Field Alert Reporting Project
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 12 - Pharmaceutical Quality
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Drug Shortages: Causes, Current State and Path Forward
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 12 - Pharmaceutical Quality
Day: Wednesday, Jun, 26
Time: 10:15AM - 11:45AM
Title: TransCelerate’s Collaborative Approach to Risk-based Monitoring: The Methodology
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 12 - Pharmaceutical Quality;Track 14 - Clinical Safety and Pharmacovigilance;Track 21 - Late Breaker
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Implementation of Quality by Design: Progress, Challenges and Opportunities - Industry Perspective
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 12 - Pharmaceutical Quality
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Challenges for Stable Supply of Drugs and International Cooperation
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 12 - Pharmaceutical Quality;Track 18 - Global Regulatory
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Implementation of Quality by Design: Progress, Challenges and Opportunities - FDA Perspective
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 12 - Pharmaceutical Quality
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Postapproval Change Management: Challenges and Opportunities
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 12 - Pharmaceutical Quality
Day: Thursday, Jun, 27
Time: 9:00AM - 10:30AM

Title: #22: Global Reimbursement Systems: A Market Access Perspective
Event Type: TUTORIAL
Credits: IACET
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
Day: Sunday, Jun, 23
Time: 8:30AM - 12:00PM
Title: Using Epidemiologic Methods to Advance Comparative Effectiveness Research
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: Payer Collaborations with Pharma: Real-world Evidence to Improve Patient Outcomes and Influence the Pipeline
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Deloitte Innovation Theater: Race for Real World Data - Outcomes Data and Analytics: Uses, Approach and Issues
Event Type: SPECSESS
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA);Track 07 - Processes and Technologies for Clinical Research;Track 01 - Clinical Operations;Track 23 - Innovation Theater
Day: Tuesday, Jun, 25
Time: 9:40AM - 10:10AM
Title: Big Data: Impact on Innovation
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) ;Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA);Track 15 - Statistical Science and Quantitative Thinking;Track 07 - Processes and Technologies for Clinical Research;Track 14 - Clinical Safety and Pharmacovigilance;Track 01 - Clinical Operations
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: Bringing the Views of “Payer Regulators” into Product Development to Align Label Outcomes and Safety with Patient Access
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: Utilizing Electronic Medical Records as an Innovative Methodology for Evaluating Therapeutic Effectiveness
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: The Environment for Health Care Decision-making: Collecting, Using and Understanding Comparative Effectiveness Research
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: SAS Innovation Theater: Picture This: Bringing Clinical Data to Life
Event Type: SPECSESS
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA);Track 07 - Processes and Technologies for Clinical Research;Track 14 - Clinical Safety and Pharmacovigilance;Track 23 - Innovation Theater
Day: Wednesday, Jun, 26
Time: 12:15PM - 1:00PM
Title: The 2012 US Payer Landscape: Results from a Survey of Medical and Pharmacy Directors on Comparative Effectiveness Research
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Informing Regulatory and Health Technology Assessment (HTA) Decision-making Processes: An Integrated Approach to Life Cycle Management
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Patient-centered Predictive Modeling and Its Role in Creating a Learning Health System
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
Day: Thursday, Jun, 27
Time: 9:00AM - 10:30AM

Title: #56: Risk Communications
Event Type: TUTORIAL
Credits: ACPE, CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Sunday, Jun, 23
Time: 9:00AM - 5:00PM
Title: #30: Analysis of Safety Data from Clinical Trials
Event Type: TUTORIAL
Credits: ACPE, CME, IACET
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Sunday, Jun, 23
Time: 1:00PM - 4:30PM
Title: #31: Highlights of the New Pharmacovigilance Legislation in the EU: Key Points to be Taken into Account for Successful Implementation and Lessons Learned
Event Type: TUTORIAL
Credits: CME, IACET
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Sunday, Jun, 23
Time: 1:00PM - 4:30PM
Title: Electronic Health Records (EHRs) in Signal Detection and Evaluation
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: Narrative Medicine and Pharmacovigilance
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: The New Standards for the Identification of Medicinal Products and Individual Case Safety Reporting Applied in Pharmacovigilance
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: Characterizing Drug Shortages and Their Causes: Anticipating Future Trends
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: Aligning Statistical Science and Regulatory Practices for Expedited Safety Reporting
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Social Media, Mobile Applications and Patient Support Programs: Challenges and Solutions for Handling Drug Safety Information
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Big Data: Impact on Innovation
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) ;Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA);Track 15 - Statistical Science and Quantitative Thinking;Track 07 - Processes and Technologies for Clinical Research;Track 14 - Clinical Safety and Pharmacovigilance;Track 01 - Clinical Operations
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: EU Update: PROTECT and EnCePP
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: Cambridge Semantics Innovation Theater: How Can Technology Change the Way Pharmas Handle Risk? Innovations in Drug Safety and Business Development
Event Type: SPECSESS
Tracks: Track 07 - Processes and Technologies for Clinical Research;Track 14 - Clinical Safety and Pharmacovigilance;Track 23 - Innovation Theater
Day: Tuesday, Jun, 25
Time: 12:15PM - 1:00PM
Title: Periodic Reporting in Drug Safety: From Safety Updates to Continuous Signal Monitoring and Benefit-risk Evaluations
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Quality Assurance for Signal Detection Programs
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Risk Management in the US, EU and Japan: The Challenges of Diversity
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: FDA-Health Canada Regulatory Cooperation Council (RCC) Town Hall
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 14 - Clinical Safety and Pharmacovigilance;Track 18 - Global Regulatory;Track 01 - Clinical Operations
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Molecular Predictors of Drug-induced Harm: From Clinical Development to Postmarketing Surveillance
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Pharmacovigilance Update for Japan, Developing Asia and Latin America
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Advancing Alzheimer’s Innovation: A Call to Action
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 08 - Regulatory Affairs and Submissions;Track 10 - Public Policy/ Health Care Compliance/ Law;Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) ;Track 16 - Professional Development;Track 17 - Rare/Orphan Diseases;Track 07 - Processes and Technologies for Clinical Research;Track 14 - Clinical Safety and Pharmacovigilance;Track 01 - Clinical Operations
Day: Wednesday, Jun, 26
Time: 10:15AM - 11:45AM
Title: SAS Innovation Theater: Picture This: Bringing Clinical Data to Life
Event Type: SPECSESS
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA);Track 07 - Processes and Technologies for Clinical Research;Track 14 - Clinical Safety and Pharmacovigilance;Track 23 - Innovation Theater
Day: Wednesday, Jun, 26
Time: 12:15PM - 1:00PM
Title: TransCelerate’s Collaborative Approach to Risk-based Monitoring: The Methodology
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 12 - Pharmaceutical Quality;Track 14 - Clinical Safety and Pharmacovigilance;Track 21 - Late Breaker
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: An Interactive Course on Likelihood Ratio Test-based Method for Signal Detection
Event Type: WORKSHOP
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Developing a Patient Aid to Make Information about Treatment Benefits, Harms and Uncertainties Meaningful to Individual Patients and Enhance Their Decisions
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Herbal-induced Liver Injury (HILI): How That May Impact Rx Benefit-Risk
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance;Track 19 - Communities Showcase
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Tracking Misuse and Abuse of Marketed Products: Is Pharma Doing All that It Can?
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Thursday, Jun, 27
Time: 9:00AM - 10:30AM
Title: Coding with Confidence
Event Type: WORKSHOP
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Thursday, Jun, 27
Time: 9:00AM - 10:30AM
Title: Off-target Blood Pressure Changes and Evaluation in Drug Development: Safety, Clinical and Regulatory Considerations
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Thursday, Jun, 27
Time: 10:45AM - 12:15PM

Title: Hot Topics in Statistics: Working Together Effectively to Transform Our Science
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: Key Multiplicity Issues in Clinical Trials
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: Biomarkers for Drug Development: How Are We Dealing with the Challenges?
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Big Data: Impact on Innovation
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) ;Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA);Track 15 - Statistical Science and Quantitative Thinking;Track 07 - Processes and Technologies for Clinical Research;Track 14 - Clinical Safety and Pharmacovigilance;Track 01 - Clinical Operations
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: Statistical Considerations When Developing Antibacterial Treatments
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: Looking Closer into the Utility of Adaptive Approaches
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Analysis Data Standards: Developing, Applying, Submitting and Reviewing
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: Quantitative Benefit-risk in the Current Regulatory Environment and the Implications for Clinical Statisticians
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Clinical Trial Simulations and Modeling
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Noninferiority Trials in Drug Development: Clinical, Statistical and Regulatory Perspectives
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Some Innovative Approaches to Handling Missing Data Problems in Clinical Trials
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking
Day: Thursday, Jun, 27
Time: 9:00AM - 10:30AM
Title: Bayesian Methods in Medical Product Development and Comparative Effectiveness
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking
Day: Thursday, Jun, 27
Time: 10:45AM - 12:15PM

Title: #25: Leadership: How to Organize and Lead People in Group Work
Event Type: TUTORIAL
Credits: IACET, PMI
Tracks: Track 16 - Professional Development
Day: Sunday, Jun, 23
Time: 8:30AM - 12:00PM
Title: #55: Overview of Drug Development
Event Type: TUTORIAL
Credits: IACET, PMI
Tracks: Track 16 - Professional Development
Day: Sunday, Jun, 23
Time: 9:00AM - 5:00PM
Title: Next Generation Medical Information Call Center
Event Type: SESSION
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison;Track 16 - Professional Development;Track 01 - Clinical Operations;Track 22 - White Paper Showcase
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: Challenges and Solutions for Professional Development and Training of Clinical/Nonclinical Staff
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 16 - Professional Development
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: The Secret of Stellar Careers: Serendipity plus Planning = Success
Event Type: FORUM
Credits: IACET
Tracks: Track 16 - Professional Development
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: DNA of Entrepreneurs: Calculated Risk-taking and Bringing Game-changing Technology to the World
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 16 - Professional Development
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Advanced Presentation Skills
Event Type: WORKSHOP
Credits: IACET
Tracks: Track 16 - Professional Development
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: DIA 2013 Student Forum: Getting a Job and Developing a Career
Event Type: FORUM
Credits: IACET
Tracks: Track 16 - Professional Development
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: Learning to Share-Sharing To Learn: How an Industry Learns to Honor Its Volunteers
Event Type: SESSION
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 08 - Regulatory Affairs and Submissions;Track 16 - Professional Development;Track 01 - Clinical Operations;Track 22 - White Paper Showcase
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: So You Want to Foster Innovation: A Neuroscience Primer on How Creative Ideas Arise from the Brain
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 16 - Professional Development
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: Advanced Presentation Skills
Event Type: WORKSHOP
Credits: IACET
Tracks: Track 16 - Professional Development
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: How Economic and Technological Change Can Affect Professional Expectations: Case Studies in Succeeding in the Midst of Change
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 16 - Professional Development
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Advancing Alzheimer’s Innovation: A Call to Action
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 08 - Regulatory Affairs and Submissions;Track 10 - Public Policy/ Health Care Compliance/ Law;Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) ;Track 16 - Professional Development;Track 17 - Rare/Orphan Diseases;Track 07 - Processes and Technologies for Clinical Research;Track 14 - Clinical Safety and Pharmacovigilance;Track 01 - Clinical Operations
Day: Wednesday, Jun, 26
Time: 10:15AM - 11:45AM
Title: Successful Mentoring Relationships
Event Type: WORKSHOP
Credits: CME, IACET, RN
Tracks: Track 16 - Professional Development
Day: Wednesday, Jun, 26
Time: 10:15AM - 11:45AM
Title: Submitting an Abstract for the DIA 2014 50th Annual Meeting
Event Type: WORKSHOP
Credits: IACET
Tracks: Track 16 - Professional Development
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Transition from Subject Matter Expert (SME) to Subject Matter Educator Extraordinaire (SMEE)!
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 16 - Professional Development
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Ensuring Patient-centered Care: Partnering with Patient Advocacy
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 16 - Professional Development
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Mobile Learning and Social Media Symposium
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 16 - Professional Development
Day: Thursday, Jun, 27
Time: 9:00AM - 10:30AM
Title: Cultural Awareness and Collaboration
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 16 - Professional Development
Day: Thursday, Jun, 27
Time: 10:45AM - 12:15PM

Title: Roundtable on Personalized Therapy Innovation in Rare Disease: Focus on Public Policy
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 17 - Rare/Orphan Diseases
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: Research Advances for Rare Diseases and Orphan Products
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 17 - Rare/Orphan Diseases
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Is There a Recipe for Successful Implementation of Registries for Rare Diseases?
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 17 - Rare/Orphan Diseases
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Development for Rare Disease Treatments
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 17 - Rare/Orphan Diseases
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: Movie Documentary: RARE
Event Type: SPECSESS
Tracks: Track 17 - Rare/Orphan Diseases;Track 21 - Late Breaker
Day: Tuesday, Jun, 25
Time: 5:30PM - 7:30PM
Title: Models for Genomic Research Success: Empowering Patient-Researcher Relationships and the Emerging Role of Crowd Sourcing in Rare Disease Research
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 17 - Rare/Orphan Diseases
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Advancing Alzheimer’s Innovation: A Call to Action
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 08 - Regulatory Affairs and Submissions;Track 10 - Public Policy/ Health Care Compliance/ Law;Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) ;Track 16 - Professional Development;Track 17 - Rare/Orphan Diseases;Track 07 - Processes and Technologies for Clinical Research;Track 14 - Clinical Safety and Pharmacovigilance;Track 01 - Clinical Operations
Day: Wednesday, Jun, 26
Time: 10:15AM - 11:45AM
Title: Rising to the Challenge of Developing Novel Orphan Medicines for the Global Market
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 17 - Rare/Orphan Diseases
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Rescuing and Repurposing Drugs: Challenges and Opportunities
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 17 - Rare/Orphan Diseases
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Movie Documentary: Here.Us.Now.
Event Type: SPECSESS
Tracks: Track 17 - Rare/Orphan Diseases;Track 21 - Late Breaker
Day: Wednesday, Jun, 26
Time: 5:30PM - 7:30PM
Title: The Not So Rare Challenge that Faces Rare Disease Development: Demonstrate Value
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 17 - Rare/Orphan Diseases
Day: Thursday, Jun, 27
Time: 9:00AM - 10:30AM

Title: Regulatory Environment in the US: CDRH Panel Discusses What's on the Horizon
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products;Track 18 - Global Regulatory
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: CBER Town Hall
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 18 - Global Regulatory
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: European Town Hall: Implementation of New Safety Legislation and Other Hot Topics
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 18 - Global Regulatory
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: Cooperation Among Regulators: Impact on Stakeholders
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 10 - Public Policy/ Health Care Compliance/ Law;Track 18 - Global Regulatory
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: Pharmaceuticals and Medical Devices Agency (PMDA) Town Hall
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 18 - Global Regulatory
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Convergence in Regulatory Science Across the Strait
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 18 - Global Regulatory
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Korea Forum: Introduction to the Korean Ministry of Food and Drug Safety (MFDS) and Government R&D Program
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 18 - Global Regulatory
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: FDA-Health Canada Regulatory Cooperation Council (RCC) Town Hall
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 14 - Clinical Safety and Pharmacovigilance;Track 18 - Global Regulatory;Track 01 - Clinical Operations
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Canadian Approaches to Regulatory Modernization and International Engagement
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 18 - Global Regulatory
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Challenges for Stable Supply of Drugs and International Cooperation
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 12 - Pharmaceutical Quality;Track 18 - Global Regulatory
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Latin America Town Hall
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 18 - Global Regulatory
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: CDER Town Hall: Part 1 of 2
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 18 - Global Regulatory
Day: Thursday, Jun, 27
Time: 9:00AM - 10:30AM
Title: CDER Town Hall: Part 2 of 2
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 18 - Global Regulatory
Day: Thursday, Jun, 27
Time: 10:45AM - 12:15PM

Title: How Can Translational Medicine Fill the Gaps in Life Sciences Industries?
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 19 - Communities Showcase;Track 01 - Clinical Operations
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: Defining Clinical Trial Innovation: Challenges and Opportunities for 2013
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 19 - Communities Showcase;Track 01 - Clinical Operations
Day: Monday, Jun, 24
Time: 2:30PM - 4:00PM
Title: Using Risk-based Signal Detection Methods to Identify Sites with Potential GCP Problems: Better Than a Crystal Ball
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) ;Track 19 - Communities Showcase
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Achieving Innovative Technology Results
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research;Track 19 - Communities Showcase
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: First-in-Human Studies: How Much Complexity Is Too Much?
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 19 - Communities Showcase
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: The Evolving Clinical Trial Disclosure Global Landscape
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 19 - Communities Showcase
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM
Title: Bringing SPIRIT into Protocols, Structuring Content and Expanding This Work to Noninterventional Postmarketing Protocols
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison;Track 19 - Communities Showcase
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Clinical Outcome Assessment for Clinical Trials: PROs, ClinROs, and ObsROs
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 08 - Regulatory Affairs and Submissions;Track 19 - Communities Showcase
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: Current Regulatory Landscape Impacting Medical and Scientific Communications
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison;Track 19 - Communities Showcase
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Herbal-induced Liver Injury (HILI): How That May Impact Rx Benefit-Risk
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance;Track 19 - Communities Showcase
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM

Title: Reinventing the R&D Business Model: Heeding the President's PCAST Report on Innovation
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 20 - Executive Program;Track 01 - Clinical Operations
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Where Research, Medicine and Care Converge: A CMO Roundtable Discussion
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 20 - Executive Program;Track 01 - Clinical Operations
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM

Title: Movie Documentary: RARE
Event Type: SPECSESS
Tracks: Track 17 - Rare/Orphan Diseases;Track 21 - Late Breaker
Day: Tuesday, Jun, 25
Time: 5:30PM - 7:30PM
Title: Collaborating to Streamline Drug Development: Are We Making Progress?
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 08 - Regulatory Affairs and Submissions;Track 01 - Clinical Operations;Track 21 - Late Breaker
Day: Wednesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: TransCelerate’s Collaborative Approach to Risk-based Monitoring: The Methodology
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 12 - Pharmaceutical Quality;Track 14 - Clinical Safety and Pharmacovigilance;Track 21 - Late Breaker
Day: Wednesday, Jun, 26
Time: 1:45PM - 3:15PM
Title: TransCelerate’s Collaborative Approach for Site Qualification and Training Efficiencies
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) ;Track 01 - Clinical Operations;Track 21 - Late Breaker
Day: Wednesday, Jun, 26
Time: 4:00PM - 5:30PM
Title: Movie Documentary: Here.Us.Now.
Event Type: SPECSESS
Tracks: Track 17 - Rare/Orphan Diseases;Track 21 - Late Breaker
Day: Wednesday, Jun, 26
Time: 5:30PM - 7:30PM

Title: Next Generation Medical Information Call Center
Event Type: SESSION
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison;Track 16 - Professional Development;Track 01 - Clinical Operations;Track 22 - White Paper Showcase
Day: Monday, Jun, 24
Time: 11:00AM - 12:30PM
Title: Moving to a Standards-based, Agile Clinical Development Lifecycle
Event Type: SESSION
Tracks: Track 08 - Regulatory Affairs and Submissions;Track 07 - Processes and Technologies for Clinical Research;Track 01 - Clinical Operations;Track 22 - White Paper Showcase
Day: Tuesday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Circulating Tumor Cells (CTCs) as a Biomarker Approach in Oncology
Event Type: SESSION
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development;Track 08 - Regulatory Affairs and Submissions;Track 01 - Clinical Operations;Track 22 - White Paper Showcase
Day: Tuesday, Jun, 25
Time: 10:15AM - 11:45AM
Title: Learning to Share-Sharing To Learn: How an Industry Learns to Honor Its Volunteers
Event Type: SESSION
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 08 - Regulatory Affairs and Submissions;Track 16 - Professional Development;Track 01 - Clinical Operations;Track 22 - White Paper Showcase
Day: Tuesday, Jun, 25
Time: 1:45PM - 3:15PM
Title: Four Ways to Accelerate Clinical Portfolio Strategy
Event Type: SESSION
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 08 - Regulatory Affairs and Submissions;Track 02 - Project/Portfolio Management and Strategic Planning;Track 01 - Clinical Operations;Track 22 - White Paper Showcase
Day: Tuesday, Jun, 25
Time: 4:00PM - 5:30PM

Title: IntraLinks Innovation Theater: Crossing the Threshold – Clinical Portals from a Site Perspective
Event Type: SPECSESS
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies;Track 01 - Clinical Operations;Track 23 - Innovation Theater
Day: Monday, Jun, 24
Time: 1:00PM - 1:45PM
Title: Deloitte Innovation Theater: Race for Real World Data - Outcomes Data and Analytics: Uses, Approach and Issues
Event Type: SPECSESS
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA);Track 07 - Processes and Technologies for Clinical Research;Track 01 - Clinical Operations;Track 23 - Innovation Theater
Day: Tuesday, Jun, 25
Time: 9:40AM - 10:10AM
Title: Cambridge Semantics Innovation Theater: How Can Technology Change the Way Pharmas Handle Risk? Innovations in Drug Safety and Business Development
Event Type: SPECSESS
Tracks: Track 07 - Processes and Technologies for Clinical Research;Track 14 - Clinical Safety and Pharmacovigilance;Track 23 - Innovation Theater
Day: Tuesday, Jun, 25
Time: 12:15PM - 1:00PM
Title: INC Research Innovation Theater: Innovating Clinical Development Through Data-driven Operational Strategy
Event Type: SPECSESS
Tracks: Track 07 - Processes and Technologies for Clinical Research;Track 01 - Clinical Operations;Track 23 - Innovation Theater
Day: Tuesday, Jun, 25
Time: 3:25PM - 3:55PM
Title: SAS Innovation Theater: Picture This: Bringing Clinical Data to Life
Event Type: SPECSESS
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA);Track 07 - Processes and Technologies for Clinical Research;Track 14 - Clinical Safety and Pharmacovigilance;Track 23 - Innovation Theater
Day: Wednesday, Jun, 26
Time: 12:15PM - 1:00PM

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Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products (10)

Track 10 - Public Policy/ Health Care Compliance/ Law (12)

Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) (16)

Track 12 - Pharmaceutical Quality (13)

Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA) (12)

Track 14 - Clinical Safety and Pharmacovigilance (27)

Track 15 - Statistical Science and Quantitative Thinking (12)

Track 16 - Professional Development (19)

Track 17 - Rare/Orphan Diseases (11)

Track 18 - Global Regulatory (13)

Track 19 - Communities Showcase (10)

Track 20 - Executive Program (2)

Track 21 - Late Breaker (5)

Track 22 - White Paper Showcase (5)

Track 23 - Innovation Theater (5)

ALL
Clinical Operations (Track 01)
Project/Portfolio Management and Strategic Planning (Track 02)
Innovative Partnering Models and Outsourcing Strategies (Track 03)
Nonclinical and Translational Development/Early Phase Clinical Development (Track 04)
Regulation of Product Advertising and Marketing in an Ever-changing World (Track 05)
Medical Communication, Medical Writing and Medical Science Liaison (Track 06)
Processes and Technologies for Clinical Research (Track 07)
Regulatory Affairs and Submissions (Track 08)
Medical Devices, In Vitro Diagnostics, and Combination Products (Track 09)
Public Policy/ Health Care Compliance/ Law (Track 10)
Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) (Track 11)
Pharmaceutical Quality (Track 12)
Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA) (Track 13)
Clinical Safety and Pharmacovigilance (Track 14)
Statistical Science and Quantitative Thinking (Track 15)
Professional Development (Track 16)
Rare/Orphan Diseases (Track 17)
Global Regulatory (Track 18)
Communities Showcase (Track 19)
Executive Program (Track 20)
Late Breaker (Track 21)
White Paper Showcase (Track 22)
Innovation Theater (Track 23)

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Track 01 - Clinical Operations (44)

Track 02 - Project/Portfolio Management and Strategic Planning (21)

Track 03 - Innovative Partnering Models and Outsourcing Strategies (23)

Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development (13)

Track 05 - Regulation of Product Advertising and Marketing in an Ever-changing World (4)

Track 06 - Medical Communication, Medical Writing and Medical Science Liaison (17)

Track 07 - Processes and Technologies for Clinical Research (31)

Track 08 - Regulatory Affairs and Submissions (49)

Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products (10)

Track 10 - Public Policy/ Health Care Compliance/ Law (12)

Track 11 - Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) (16)

Track 12 - Pharmaceutical Quality (13)

Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA) (12)

Track 14 - Clinical Safety and Pharmacovigilance (27)

Track 15 - Statistical Science and Quantitative Thinking (12)

Track 16 - Professional Development (19)

Track 17 - Rare/Orphan Diseases (11)

Track 18 - Global Regulatory (13)

Track 19 - Communities Showcase (10)

Track 20 - Executive Program (2)

Track 21 - Late Breaker (5)

Track 22 - White Paper Showcase (5)

Track 23 - Innovation Theater (5)