Full Program

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

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

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

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)

Title: #25: Leadership: How to Organize and Lead People in Group Work
Event Type: TUTORIAL
Credits: IACET, PMI
Tracks: Track 16 - Professional Development

Title: #53: Clinical Statistics for Nonstatisticians
Event Type: TUTORIAL
Credits: ACPE, CME, IACET
Tracks: Track 01 - Clinical Operations

Title: #51: Quality Oversight of CROs-Clinical Vendors
Event Type: TUTORIAL
Credits: IACET
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies

Title: #54: Art of Writing a Clinical Overview
Event Type: TUTORIAL
Credits: IACET
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison

Title: #50: Understanding and Navigating the Regulatory System in China
Event Type: TUTORIAL
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions

Title: #52: Regulatory Affairs for Biologics
Event Type: TUTORIAL
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions

Title: #57: Preparing for a US FDA Advisory Committee Meeting
Event Type: TUTORIAL
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions

Title: #56: Risk Communications
Event Type: TUTORIAL
Credits: ACPE, CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance

Title: #55: Overview of Drug Development
Event Type: TUTORIAL
Credits: IACET, PMI
Tracks: Track 16 - Professional Development

Title: #40: Investigative Site Boot Camp: Innovative Solutions to your Operational Challenges
Event Type: TUTORIAL
Credits: CME, IACET
Tracks: Track 01 - Clinical Operations

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

Title: #32: Understanding Translational Medicine: Benefits and Innovative Approaches
Event Type: TUTORIAL
Credits: CME, IACET
Tracks: Track 08 - Regulatory Affairs and Submissions

Title: #34: Fourteen Steps from Research to Development
Event Type: TUTORIAL
Credits: CME, IACET
Tracks: Track 08 - Regulatory Affairs and Submissions

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

Title: #30: Analysis of Safety Data from Clinical Trials
Event Type: TUTORIAL
Credits: ACPE, CME, IACET
Tracks: Track 14 - Clinical Safety and Pharmacovigilance

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

Title: Opening Plenary
Event Type: FORUM

Title: Shape Your Cost with Hard and Soft Coverage Analysis Trends
Event Type: WORKSHOP
Credits: CME, IACET, PMI, RN
Tracks: Track 01 - Clinical Operations

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

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

Title: Portfolio Management Symposium
Event Type: SYMPOSIUM
Credits: IACET, PMI
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning

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

Title: Innovative Partnerships for mHealth
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies

Title: Global Symposium
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development

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

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

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

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

Title: Managing Data at Arms' Length: China
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research

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

Title: Pediatric Drug Development: A New Paradigm Under FDASIA
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions

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

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

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)

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)

Title: Chemistry, Manufacturing and Controls (CMC) Regulatory Landscape in Emerging Markets
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 12 - Pharmaceutical Quality

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

Title: Narrative Medicine and Pharmacovigilance
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance

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

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

Title: CBER Town Hall
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 18 - Global Regulatory

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

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

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

Title: Global Clinical Trials: The Role of Emerging Markets
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations

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

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

Title: Implementing Regulatory Outsourcing Partnerships: New Trends and Practices
Event Type: FORUM
Credits: IACET
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies

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

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

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

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

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

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

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

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

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)

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)

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)

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

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

Title: Key Multiplicity Issues in Clinical Trials
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking

Title: The Secret of Stellar Careers: Serendipity plus Planning = Success
Event Type: FORUM
Credits: IACET
Tracks: Track 16 - Professional Development

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

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

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

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

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

Title: Making CRO-Sponsor Partnerships Work: Executive Roundtable
Event Type: FORUM
Credits: IACET, PMI
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies

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

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

Title: The Regulatory Writing Game Show
Event Type: WORKSHOP
Credits: IACET
Tracks: Track 06 - Medical Communication, Medical Writing and Medical Science Liaison

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

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

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

Title: A Regulatory Perspective of Biosimilars in Emerging Markets
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions

Title: Expediting Drug Development and Review for Serious Conditions
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions

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

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

Title: Ethical Issues in Clinical Trials
Event Type: WORKSHOP
Credits: ACPE, CME, IACET, RN
Tracks: Track 10 - Public Policy/ Health Care Compliance/ Law

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)

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

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

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)

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

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

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

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

Title: Research Advances for Rare Diseases and Orphan Products
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 17 - Rare/Orphan Diseases

Title: Pharmaceuticals and Medical Devices Agency (PMDA) Town Hall
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 18 - Global Regulatory

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

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

Title: Domestic and Global Trends in Clinical Trial Budgeting
Event Type: WORKSHOP
Credits: CME, IACET, PMI, RN
Tracks: Track 01 - Clinical Operations

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

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

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

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

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

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

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

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

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

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

Title: Strategies for the Development and Registration of Antibody Drug Conjugates
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 12 - Pharmaceutical Quality

Title: EU Update: PROTECT and EnCePP
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance

Title: Statistical Considerations When Developing Antibacterial Treatments
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking

Title: Advanced Presentation Skills
Event Type: WORKSHOP
Credits: IACET
Tracks: Track 16 - Professional Development

Title: DIA 2013 Student Forum: Getting a Job and Developing a Career
Event Type: FORUM
Credits: IACET
Tracks: Track 16 - Professional Development

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

Title: Enrollment Analytics: Moving Beyond the Funnel
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations

Title: Taking the Measure of Metrics
Event Type: SYMPOSIUM
Credits: CME, IACET, PMI, RN
Tracks: Track 01 - Clinical Operations

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

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

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

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

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

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

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

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

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

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

Title: Innovative Computerized System Validation and Auditing
Event Type: FORUM
Credits: CME, IACET, PMI, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research

Title: US and EU Regulatory Update of Clinical Trial Disclosure
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions

Title: Electronic Submissions in PDUFA V
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions

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

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

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

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)

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

Title: Quality Assurance for Signal Detection Programs
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance

Title: Looking Closer into the Utility of Adaptive Approaches
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking

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

Title: Convergence in Regulatory Science Across the Strait
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 18 - Global Regulatory

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

Title: Approaches to Risk-based Monitoring
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations

Title: Evaluating Sites for Optimum Site Selection and Performance
Event Type: SESSION
Credits: CME, IACET, PMI, RN
Tracks: Track 01 - Clinical Operations

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

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

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

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

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

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

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

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

Title: Labeling and Patient Medical Information (PMI)
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions

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)

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

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

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

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

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)

Title: Lessons Learned from the EMA-FDA Quality by Design (QbD) Pilot
Event Type: SESSION
Credits: IACET
Tracks: Track 12 - Pharmaceutical Quality

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)

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

Title: Analysis Data Standards: Developing, Applying, Submitting and Reviewing
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking

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

Title: Advanced Presentation Skills
Event Type: WORKSHOP
Credits: IACET
Tracks: Track 16 - Professional Development

Title: Development for Rare Disease Treatments
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 17 - Rare/Orphan Diseases

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

Title: Movie Documentary: RARE
Event Type: SPECSESS
Tracks: Track 17 - Rare/Orphan Diseases;Track 21 - Late Breaker

Title: Clinical Trial Design for Optimal Patient Recruitment and Retention
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations

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

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

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

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

Title: Unique Nonprofit-Industry Partnerships to Develop and Disseminate Technology
Event Type: SESSION
Credits: IACET
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies

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

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

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

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

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

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

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

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

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

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

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

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

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)

Title: Current Developments in the Automated NDA Field Alert Reporting Project
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 12 - Pharmaceutical Quality

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)

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

Title: Pharmacovigilance Update for Japan, Developing Asia and Latin America
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance

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

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

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

Title: Study Startup Symposium
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations

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

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

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

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

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

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

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

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

Title: EDC Insights: Before, During, and After
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research

Title: Advancing Endpoint Adjudication
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research

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

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

Title: Drug Shortages: Causes, Current State and Path Forward
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 12 - Pharmaceutical Quality

Title: Successful Mentoring Relationships
Event Type: WORKSHOP
Credits: CME, IACET, RN
Tracks: Track 16 - Professional Development

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

Title: Using Big Data to Design Smarter Studies
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations

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

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

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

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

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

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

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

Title: FDASIA Patient Provisions: One Year Later
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions

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

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

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

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

Title: The Science of Compliance
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 10 - Public Policy/ Health Care Compliance/ Law

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)

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

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)

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

Title: Clinical Trial Simulations and Modeling
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking

Title: Submitting an Abstract for the DIA 2014 50th Annual Meeting
Event Type: WORKSHOP
Credits: IACET
Tracks: Track 16 - Professional Development

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

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

Title: Canadian Approaches to Regulatory Modernization and International Engagement
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 18 - Global Regulatory

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

Title: Overcoming Unique Challenges of Pediatric Studies
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations

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

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

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

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

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

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

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

Title: Data Standards Strategy
Event Type: SESSION
Credits: CME, IACET, PMI, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research

Title: Global Pediatric Development: Next Steps
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions

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

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

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

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

Title: Ethical Issues in Clinical Trials
Event Type: WORKSHOP
Credits: ACPE, CME, IACET, RN
Tracks: Track 10 - Public Policy/ Health Care Compliance/ Law

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)

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

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

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)

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

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

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

Title: Ensuring Patient-centered Care: Partnering with Patient Advocacy
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 16 - Professional Development

Title: Rescuing and Repurposing Drugs: Challenges and Opportunities
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 17 - Rare/Orphan Diseases

Title: Latin America Town Hall
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 18 - Global Regulatory

Title: Movie Documentary: Here.Us.Now.
Event Type: SPECSESS
Tracks: Track 17 - Rare/Orphan Diseases;Track 21 - Late Breaker

Title: Parents as Partners: Engaging Caregivers for Pediatric Trials
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations

Title: Hot Topics in Clinical Supplies
Event Type: SYMPOSIUM
Credits: IACET
Tracks: Track 01 - Clinical Operations

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

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

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

Title: eDM From Three Sponsors
Event Type: SESSION
Credits: IACET
Tracks: Track 07 - Processes and Technologies for Clinical Research

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

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

Title: Medical Devices Global Symposium
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 09 - Medical Devices, In Vitro Diagnostics, and Combination Products

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)

Title: Postapproval Change Management: Challenges and Opportunities
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 12 - Pharmaceutical Quality

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)

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

Title: Coding with Confidence
Event Type: WORKSHOP
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance

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

Title: Mobile Learning and Social Media Symposium
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 16 - Professional Development

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

Title: CDER Town Hall: Part 1 of 2
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 18 - Global Regulatory

Title: Impact and Interventions Related to FDASIA: Increasing Diversity in Clinical Trials
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations

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

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

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

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

Title: Emerging Electronic Tools in Cardiovascular Outcomes Studies
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research

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

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

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

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)

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

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

Title: Cultural Awareness and Collaboration
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 16 - Professional Development

Title: CDER Town Hall: Part 2 of 2
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 18 - Global Regulatory