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Title: DIA 2012 Student Forum
Event Type: FORUM
Day: Sunday, Jun, 24
Time: 3:00PM - 5:00PM
Title: #20: Japan 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, 24
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, 24
Time: 8:30AM - 12:00PM
Title: #22: Utilizing Chemistry, Manufacturing, and Controls in Drug Development
Event Type: TUTORIAL
Credits: IACET
Tracks: Track 12 - Pharmaceutical Quality
Day: Sunday, Jun, 24
Time: 8:30AM - 12:00PM
Title: #23: Global Market Access: Essential Knowledge for Clinical Trial Design
Event Type: TUTORIAL
Credits: IACET
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
Day: Sunday, Jun, 24
Time: 8:30AM - 12:00PM
Title: #24: A Device Primer: 510(k)s, PMAs, IDEs
Event Type: TUTORIAL
Credits: CME, IACET
Tracks: Track 12 - Pharmaceutical Quality
Day: Sunday, Jun, 24
Time: 8:30AM - 12:00PM
Title: #30: Regulatory Affairs in the European Union: An Overview of Registration Procedures for Medicinal Products in the EU
Event Type: TUTORIAL
Credits: IACET
Tracks: Track 12 - Pharmaceutical Quality
Day: Sunday, Jun, 24
Time: 1:00PM - 4:30PM
Title: #31: Leadership: How to Organize and Lead People in Group Work
Event Type: TUTORIAL
Credits: IACET, PMI
Tracks: Track 16 - Professional Development
Day: Sunday, Jun, 24
Time: 1:00PM - 4:30PM
Title: #32: Designing, Operating and Evaluating Patient Registries
Event Type: TUTORIAL
Credits: ACPE, CME, IACET, RN
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
Day: Sunday, Jun, 24
Time: 1:00PM - 4:30PM
Title: #33: Understanding Comparative Effectiveness Research (CER) in the Biopharmaceutical Industry
Event Type: TUTORIAL
Credits: ACPE, CME, IACET, RN
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
Day: Sunday, Jun, 24
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, 24
Time: 1:00PM - 4:30PM
Title: #40: Understanding and Navigating the Regulatory System in China
Event Type: TUTORIAL
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Sunday, Jun, 24
Time: 9:00AM - 5:00PM
Title: #41: Quality Oversight of CROs - Clinical Vendors
Event Type: TUTORIAL
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Sunday, Jun, 24
Time: 9:00AM - 5:00PM
Title: #42: Regulatory Affairs for Biologics
Event Type: TUTORIAL
Credits: ACPE, IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Sunday, Jun, 24
Time: 9:00AM - 5:00PM
Title: #43: Clinical Statistics for Nonstatisticians
Event Type: TUTORIAL
Credits: ACPE, CME, IACET
Tracks: Track 01 - Clinical Operations
Day: Sunday, Jun, 24
Time: 9:00AM - 5:00PM

Title: Opening Plenary
Event Type: FORUM
Day: Monday, Jun, 25
Time: 8:00AM - 9:30AM
Title: Pediatric Drug Development Progress: 15 Years Later and Across the Globe
Event Type: FORUM
Credits: IACET
Tracks: Track 17 - Global Regulatory
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: Drug Development Strategies for Integrating Academia, Non-governmental Organizations (NGOs), and Industry Based on Experience in Neglected and Infectious Diseases
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 18 - Rare/Neglected Diseases
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: Advancing Benefit-risk Visualization and Communication
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 06 - Medical Writing and Medical Communications
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: First-in-human Challenges of Biologics and Biosimilars
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: Effective Switching from Rx to OTC Status: Maximizing Revenue and Profit From Off-Patent Products
Event Type: FORUM
Credits: ACPE, IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: Transforming Regulatory Information Into Actionable Regulatory Intelligence for Emerging Markets
Event Type: FORUM
Credits: ACPE, IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
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/Regulatory Law
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: Companion Diagnostics: Current and Future Developments
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 09 - Medical Diagnostics and Devices
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: ICH Update on Pharmaceutical Quality
Event Type: FORUM
Credits: ACPE, IACET
Tracks: Track 12 - Pharmaceutical Quality
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: Best Practices in Managing Alliances: Using the Balanced Scorecard Methodology to Align Strategy and Operational Execution
Event Type: WORKSHOP
Credits: IACET, PMI
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: Translational Medicine in Africa: Challenges and Opportunities for Product Development
Event Type: SESSION
Credits: IACET
Tracks: Track 16 - Professional Development
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: Defining Quality in Clinical Trials
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 11 - Compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Quality Assurance (QA)
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: Hot Topics in Statistics: Industry, CRO, Academic, and Regulatory Perspectives
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: Approaches to Postapproval Pediatric Safety Surveillance
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: The Impact of Social Media on Product Promotion and Pharmacovigilance
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: Data Quality by Design (DQbD) to Improve the Quality of Clinical Trial Data in Multiregional Clinical Trials (MRCTs)
Event Type: SESSION
Credits: IACET
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: Overcoming Organizational Resistance to Portfolio Management
Event Type: SESSION
Credits: IACET, PMI
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: Investigator Site Relationship Management Workshop
Event Type: WORKSHOP
Credits: CME, IACET, PMI, RN
Tracks: Track 01 - Clinical Operations
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: EMRs for Clinical Research: Hype versus Reality - A Management Primer
Event Type: SESSION
Credits: IACET
Tracks: Track 01 - Clinical Operations
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: Clinical Supply Chain Symposium
Event Type: SYMPOSIUM
Credits: IACET, PMI
Tracks: Track 01 - Clinical Operations
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: New Ways to Learn What Happens to Patients AFTER Approval
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: European Town Hall: Part 1 of 2- Hot Topics in Europe
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 17 - Global Regulatory
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: Standards for Patients: Collaborations to Innovate Therapy Development
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 21 - Late Breaker
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: The New Health Report 2012: Rethinking the Risk Equation in Biopharmaceutical Development and Delivery
Event Type: SESSION
Tracks: Track 22 - White Paper Showcase
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: Free Agency is Here: Exploring Workforce Impact on Clinical Outsourcing
Event Type: SESSION
Tracks: Track 22 - White Paper Showcase
Day: Monday, Jun, 25
Time: 10:00AM - 11:30AM
Title: Innovation Theater: Innovation in R&D and Commercialization Through Big Data Analytics
Event Type: SPECSESS
Day: Monday, Jun, 25
Time: 12:00PM - 12:45PM
Title: Challenges of Orphan Drugs in the US, EU, and Japan
Event Type: SESSION
Credits: IACET
Tracks: Track 18 - Rare/Neglected Diseases
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: Renal Impairment Studies Design, Conduct, and Analysis
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: Wrangling the Bestiary of Safety Documents: Coordination and Integration across Multiple Requirements
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 06 - Medical Writing and Medical Communications
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: Demystifying Approaches to the Design and Analysis of Observational Studies of Comparative Effectiveness
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: Where is the 510(k) Today
Event Type: SESSION
Credits: IACET
Tracks: Track 09 - Medical Diagnostics and Devices
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: Regulatory Roundtable on Biosimilars
Event Type: FORUM
Credits: ACPE, IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: New Challenges from Outsourcing of Regulatory Operations
Event Type: SESSION
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: Regulatory Strategies to Accelerate Approval in Emerging Markets Considering the Growing Complexity of Requirements and Supply Chains
Event Type: SESSION
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: Regulatory Collaboration / 21st Century Innovation: Views of the Heads of Health Canada, the European Medicines Agency, and the US FDA
Event Type: SESSION
Credits: ACPE, IACET
Tracks: Track 10 - Public Policy/Health Care Compliance/Regulatory Law
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: Postapproval Change Pathways in EU and US: Challenges and Opportunities for Harmonization
Event Type: SESSION
Credits: IACET
Tracks: Track 12 - Pharmaceutical Quality
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: Managing a Complex Outsourcing Collaboration
Event Type: SESSION
Credits: IACET, PMI
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: My Big Break: Women At the Top in the Biotechnology Sector
Event Type: FORUM
Credits: IACET
Tracks: Track 16 - Professional Development
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: Good Laboratory Practice (GLP): Design and Inspection Readiness
Event Type: SYMPOSIUM
Credits: IACET
Tracks: Track 11 - Compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Quality Assurance (QA)
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: Quality by Design: Is Your Clinical Trial Fit for Purpose?
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 11 - Compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Quality Assurance (QA)
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: Extrapolation to Estimate Treatment Effects in Subgroups of Special Interest
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: Epidemiologists in Industry and in CROs: Penultimate Generalists and Utterly Indispensible Scientists
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: AE Reporting in the Era of Web 2.0: The Challenges of Having a Two-Way Conversation
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: Get the Team to Take Charge!
Event Type: WORKSHOP
Credits: IACET, PMI
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: Quality by Design in Clinical Development: Blessing or Burden?
Event Type: SESSION
Credits: IACET
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: Social Media: The Promise and Pitfalls for Patient Recruitment
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: Increasing Protocol Complexity Places Challenges on Research Site Budgeting
Event Type: SESSION
Credits: IACET, PMI
Tracks: Track 01 - Clinical Operations
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: Capitalizing on Biometric Efficiencies: A Look at Data Start-up, Capture, Monitoring, and Reporting
Event Type: SESSION
Credits: CME, IACET, PMI, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: Implications of Mobile Health and Clinical Research
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: Challenges and Opportunities for Drug Development in China
Event Type: SESSION
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Monday, Jun, 25
Time: 1:30PM - 3:00PM
Title: An Update on EMA, FDA, and PMDA International Activities
Event Type: SESSION
Credits: IACET
Tracks: Track 17 - Global Regulatory
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: Drug QT Derisking: Changes in When and How
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: Communicating Drug Safety Information Using Social Media: FDA and Industry Perspectives
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 06 - Medical Writing and Medical Communications
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: Application of Quality of Evidence Assessment Tools to the Evaluation of Observational Pharmacoepidemiologic Studies
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: Vaccines: FDA and Japan Perspectives
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: Analysis and Impact of PDUFA V: How the Changes Will Affect the Work of Regulatory Affairs Professionals
Event Type: SESSION
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: Streamlining of Clinical Trial Review Process in Asian Pacific Region
Event Type: SESSION
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: Legal Jeopardy from the Conduct of Clinical Trials
Event Type: FORUM
Credits: ACPE, IACET
Tracks: Track 10 - Public Policy/Health Care Compliance/Regulatory Law
Day: Monday, Jun, 25
Time: 3:30PM - 5:30PM
Title: Opportunities for Global Harmonization of Inspection Paradigm
Event Type: SESSION
Credits: IACET
Tracks: Track 12 - Pharmaceutical Quality
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: Pharma R&D in Asia: Opportunities, Models, and Challenges
Event Type: SYMPOSIUM
Credits: IACET, PMI
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: Pre-competitive Public Private Partnerships: The Changing Model of Pharmaceutical R&D
Event Type: SESSION
Credits: IACET
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: Building International Competence in Drug Development Teams
Event Type: SYMPOSIUM
Credits: IACET
Tracks: Track 16 - Professional Development
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: Conducting Clinical Trials in Developing Countries: Challenges in Meeting Good Clinical Practice (GCP) Compliance
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 11 - Compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Quality Assurance (QA)
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: Building Quality into Clinical Trials: Regulatory Perspectives and Practical Considerations
Event Type: SESSION
Credits: IACET
Tracks: Track 11 - Compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Quality Assurance (QA)
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: Rates and Weights: Quantifying Clinical Impact and Judgment in Benefit-risk Assessment
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: Use It Early and Often: Epidemiology’s Many Roles in Clinical Development and Beyond
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: Electronic Health Records (EHR) and Medication Safety and Adherence
Event Type: SYMPOSIUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: Enhancing Decision Making and Maximizing Portfolio Value Creation Using a Novel Portfolio Management Framework
Event Type: WORKSHOP
Credits: IACET, PMI
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: Keys to Successful Project Execution: Innovative Approaches to Critical Chain, Critical Path, and Risk Management
Event Type: SESSION
Credits: IACET, PMI
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: A Day in the Life of a Clinical Research Site: What's Getting in the Way?
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: ePatient Recruitment, Study Sites, and the Digital Divide
Event Type: FORUM
Credits: IACET
Tracks: Track 01 - Clinical Operations
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: Electronic Health Records (EHR)/Electronic Data Capture (EDC) Opportunities
Event Type: SESSION
Credits: CME, IACET, PMI, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: PRO Measurement in Clinical Trials: Need for Education and Training
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: Discussion with Former Center for Devices and Radiological Health (CDRH) Management
Event Type: SESSION
Credits: IACET
Tracks: Track 09 - Medical Diagnostics and Devices
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: European Town Hall: Part 2 of 2 - Interacting With the European System
Event Type: FORUM
Credits: IACET
Tracks: Track 17 - Global Regulatory
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM
Title: Raising the Bar for Regulatory Submission Document Quality: A Collaborative, Transitional Approach
Event Type: SESSION
Tracks: Track 22 - White Paper Showcase
Day: Monday, Jun, 25
Time: 3:30PM - 5:00PM

Title: Medical Contributions to Promotional Tactics
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 06 - Medical Writing and Medical Communications
Day: Tuesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Novel Imaging Techniques Symposium
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development
Day: Tuesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Recent Advancement of HTA and Its Impact on Health Care Reform and Product Life Cycle Management in the Asian Pacific Region
Event Type: SESSION
Credits: IACET
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
Day: Tuesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Electronic Drug Registration and Listing: FDA and Industry
Event Type: SESSION
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Tuesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Legal Aspects of Clinical Trial Compliance
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 10 - Public Policy/Health Care Compliance/Regulatory Law
Day: Tuesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: The New Reality - Strategic Partnerships under Scrutiny: Are They Working, and How Long Will It Take to Ensure Success?
Event Type: FORUM
Credits: IACET, PMI
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Tuesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: NDA/BLA Statistical Review and the CDISC ADaM Data Standards
Event Type: FORUM
Credits: IACET
Tracks: Track 15 - Statistical Science and Quantitative Thinking
Day: Tuesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Data Monitoring Committee (DMC): When You Need One and When You Don't!
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Tuesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Optimizing Drug Development Portfolios: An Integrated Approach
Event Type: SESSION
Credits: IACET, PMI
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Tuesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Project and Program Management Competency Models for the (Bio) Pharmaceutical Industry
Event Type: SESSION
Credits: IACET, PMI
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Tuesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Defining Study Endpoints in 2012: The Journey Continues
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Tuesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Evolving eContent Design and Exchange for Clinical Studies
Event Type: SYMPOSIUM
Credits: CME, IACET, PMI, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Tuesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Meta-collaborations: A Call to Action
Event Type: FORUM
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Tuesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: Quality Risk Management Workshop
Event Type: WORKSHOP
Credits: IACET
Tracks: Track 12 - Pharmaceutical Quality
Day: Tuesday, Jun, 26
Time: 8:00AM - 9:30AM
Title: International Regulatory Cooperation: A Canadian Perspective
Event Type: FORUM
Credits: IACET
Tracks: Track 17 - Global Regulatory
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: Publish or Perish: Retracted Scientific Literature
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 06 - Medical Writing and Medical Communications
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: Skin-drug Biotransformation: What Testing Should We Do?
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: The Effects of NICE Technology Assessments on Prescribing and Cost-sharing Behavior in the US
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: Drug Shortages 2012: Rewind, Repeat, Recovery
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: Pediatric Development in the US: Implementation of 2007 PREA and BPCA Against a Backdrop of the EU Pediatric Legislation
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: Combination Products
Event Type: SYMPOSIUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 09 - Medical Diagnostics and Devices
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: Product Liability in the US and the EU
Event Type: SESSION
Credits: ACPE, IACET
Tracks: Track 10 - Public Policy/Health Care Compliance/Regulatory Law
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: Preparing for CMC Meetings with the FDA
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 12 - Pharmaceutical Quality
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: The Unintended Consequences of Strategic Partnerships
Event Type: SESSION
Credits: IACET, PMI
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: Latin America Town Hall
Event Type: FORUM
Credits: IACET
Tracks: Track 17 - Global Regulatory
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: Advanced Presentation Skills
Event Type: WORKSHOP
Credits: IACET
Tracks: Track 16 - Professional Development
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: Introduction to Narrative Medicine
Event Type: WORKSHOP
Credits: ACPE, CME, IACET, RN
Tracks: Track 16 - Professional Development
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: Misconduct and Management of Serious or Continued Noncompliance: What Are the Differences and Similarities?
Event Type: SESSION
Credits: IACET
Tracks: Track 11 - Compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Quality Assurance (QA)
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: FDA Draft Guidance on Multiple Endpoints in Clinical Trials
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: Comparison of National-level Drug Utilization Patterns from Large Commercial Health Care Databases with Mini-Sentinel
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: Pharmacovigilance in Japan and Risk Management Plans
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: Improving Protocol Design: Current Industry Practices and New Approaches
Event Type: SESSION
Credits: IACET
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: Optimizing Performance in Outsourced Projects in China and Other Asian Countries
Event Type: SESSION
Credits: IACET
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: The Next Patient Recruitment Frontier: Leveraging Mobile Health Care Technology (mHealth) to Recruit Patients for Clinical Trials
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: Understanding Risk-based Monitoring: Is It Art, Science, or Both?
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: Update on Collaborative Projects of the Clinical Trials Transformation Initiative (CTTI)
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: Labeling Claims Based on Patient-reported Outcome Measures: It Takes a Village!
Event Type: FORUM
Credits: ACPE, CME, IACET, PMI, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: Lessons Learned from FDA-sponsored ARRA PCOR (American Recovery and Reinvestment Act Patient Centered Outcomes Research) Data Standardization Efforts
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: Collaborative Research with Members of the Payer Community
Event Type: FORUM
Credits: IACET
Tracks: Track 20 - Executive Program: Pioneering Partnerships
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: Value of Actigraphy in Clinical Trials
Event Type: SESSION
Tracks: Track 22 - White Paper Showcase
Day: Tuesday, Jun, 26
Time: 10:00AM - 11:30AM
Title: Challenges of Precision Medicine: Diagnostics, Reimbursement, Partnership Co-development
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 20 - Executive Program: Pioneering Partnerships
Day: Tuesday, Jun, 26
Time: 12:00PM - 1:30PM
Title: Innovation Theater: ADDPLAN PE- Innovative Software for Population Enrichment Designs in Adaptive Clinical Trials
Event Type: SPECSESS
Day: Tuesday, Jun, 26
Time: 12:00PM - 12:45PM
Title: Update from the EMA-FDA Parallel Assessment Pilot
Event Type: SESSION
Credits: IACET
Tracks: Track 17 - Global Regulatory
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: Understanding the Challenges of Conducting Studies for Orphan Indications and Rare Diseases
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 18 - Rare/Neglected Diseases
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: From Design to Disclosure: Pleasing Multiple Masters
Event Type: SYMPOSIUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 06 - Medical Writing and Medical Communications
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: Product Candidate to Proof-of-concept: An Integrated Approach to Accelerate Programs
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: Registries for Evaluating Patient Outcomes: Emerging Areas of Controversy
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: An Ocean Apart? Integrating Distinct Health Authority Philosophies on Personalized Medicines and Companion Assays
Event Type: SESSION
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: Drug Rediscovery as an Innovative Tool to Meet Unmet Medical Needs
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 10 - Public Policy/Health Care Compliance/Regulatory Law
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: Practical Implementation of Knowledge Management
Event Type: SESSION
Credits: IACET
Tracks: Track 12 - Pharmaceutical Quality
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: SFDA Town Hall
Event Type: FORUM
Credits: IACET
Tracks: Track 17 - Global Regulatory
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: Collaborative Partnerships in Drug Development: An Executive Roundtable Discussion
Event Type: FORUM
Credits: IACET, PMI
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: Definition and Validation of Core Competencies to Enhance the Quality of Clinical Trials and Those Who Conduct Them
Event Type: WORKSHOP
Credits: IACET
Tracks: Track 16 - Professional Development
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: What Should You Put in a Clinical Quality Assurance (CQA) Agreement
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 11 - Compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Quality Assurance (QA)
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: Noninferiority Trial Designs: Perspectives from Academia, Industry, and a Regulatory Agency
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: Noninterventional Minimal Risk Research: A 360° Perspective
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: Stepping Up and Doing It Step by Step: Lessons Learned from Initial Endeavors Exploring Health Care Data for Signal Detection
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: Leaping the Valley of Death: Keys to Successfully Going from the Lab to the Clinic for Pharmaceutical Products
Event Type: SESSION
Credits: IACET
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: Planning Your Drug's Development Life Cycle
Event Type: SYMPOSIUM
Credits: IACET
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: Sponsors and CROs: Don't Be Misled By Your Site Performance Data
Event Type: WORKSHOP
Credits: IACET
Tracks: Track 01 - Clinical Operations
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: Effective and Efficient Monitoring as a Component of Quality Assurance in the Conduct of Clinical Trials
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: Funding Innovation and Creating Opportunities in the Device, Diagnostic, and Drug Interface
Event Type: SESSION
Credits: IACET
Tracks: Track 09 - Medical Diagnostics and Devices
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: Innovative Ways of Looking at Computer System Validation
Event Type: FORUM
Credits: ACPE, IACET
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: Implementing Adaptive Clinical Trials: A Practical Perspective
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: Investigator Budgets' Impact on Patient Enrollment and Retention: How to Improve Sponsor/CRO/Site Selection Processes
Event Type: SESSION
Credits: CME, IACET, PMI, RN
Tracks: Track 01 - Clinical Operations
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: A Challenge for the Industry: What Will it Take for a Sponsor to Use EHRs With a Regulated Research Protocol?
Event Type: FORUM
Credits: IACET
Tracks: Track 21 - Late Breaker
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: The Unique Relationship between Global Patient Recruitment and Translation Management
Event Type: SESSION
Tracks: Track 22 - White Paper Showcase
Day: Tuesday, Jun, 26
Time: 1:30PM - 3:00PM
Title: Beyond Taxonomy
Event Type: SIAC
Credits: ACPE, CME, IACET, RN
Tracks: Track 19 - SIAC Showcase
Day: Tuesday, Jun, 26
Time: 3:30PM - 4:30PM
Title: Breaking News Update: Cutting Edge Statistical Methods in Clinical Development
Event Type: SIAC
Credits: CME, IACET, RN
Tracks: Track 19 - SIAC Showcase
Day: Tuesday, Jun, 26
Time: 3:30PM - 4:30PM
Title: CDER Electronic Submissions Standards Update
Event Type: SIAC
Credits: IACET
Tracks: Track 19 - SIAC Showcase
Day: Tuesday, Jun, 26
Time: 3:30PM - 4:30PM
Title: Controversial Guidance, eSource, and Standards: How Does It All Fit Together in an eClinical World?
Event Type: SIAC
Credits: IACET
Tracks: Track 19 - SIAC Showcase
Day: Tuesday, Jun, 26
Time: 3:30PM - 4:30PM
Title: Cross-sector Innovation Brings Tailored Therapies to Patients
Event Type: SIAC
Credits: ACPE, CME, IACET, RN
Tracks: Track 19 - SIAC Showcase
Day: Tuesday, Jun, 26
Time: 3:30PM - 4:30PM
Title: Electronic Data Capture (EDC): How Much Quality is Enough?
Event Type: SIAC
Credits: CME, IACET, PMI, RN
Tracks: Track 19 - SIAC Showcase
Day: Tuesday, Jun, 26
Time: 3:30PM - 4:30PM
Title: Emerging Professionals: Optimize your Transition into the Pharmaceutical Arena
Event Type: SIAC
Credits: IACET
Tracks: Track 19 - SIAC Showcase
Day: Tuesday, Jun, 26
Time: 3:30PM - 4:30PM
Title: Evidence for the Marketplace: Bridging the Gap Between Industry, Payer, Providers, and Patients
Event Type: SIAC
Credits: ACPE, CME, IACET, RN
Tracks: Track 19 - SIAC Showcase
Day: Tuesday, Jun, 26
Time: 3:30PM - 4:30PM
Title: Reference Models and the Framework for the Destruction of Paper: How They Are Changing Our Industry
Event Type: SIAC
Credits: IACET
Tracks: Track 19 - SIAC Showcase
Day: Tuesday, Jun, 26
Time: 3:30PM - 4:30PM
Title: Globalization of Phase 1: Trends and Challenges
Event Type: SIAC
Credits: IACET, PMI
Tracks: Track 19 - SIAC Showcase
Day: Tuesday, Jun, 26
Time: 3:30PM - 4:30PM
Title: Good Pharmacovigilance Practice in a Global Environment
Event Type: SIAC
Credits: CME, IACET, PMI, RN
Tracks: Track 19 - SIAC Showcase
Day: Tuesday, Jun, 26
Time: 3:30PM - 4:30PM
Title: Hot Topics in Clinical Trial Disclosure (CTD)
Event Type: SIAC
Credits: CME, IACET, RN
Tracks: Track 19 - SIAC Showcase
Day: Tuesday, Jun, 26
Time: 3:30PM - 4:30PM
Title: Hot Topics in Regulatory Affairs Forum
Event Type: SIAC
Credits: CME, IACET, RN
Tracks: Track 19 - SIAC Showcase
Day: Tuesday, Jun, 26
Time: 3:30PM - 4:30PM
Title: How Medical Writers Are Improving Global Practice and Collaboration
Event Type: SIAC
Credits: IACET
Tracks: Track 19 - SIAC Showcase
Day: Tuesday, Jun, 26
Time: 3:30PM - 4:30PM
Title: Leveraging Technology in an Age of Readily Available Information
Event Type: SIAC
Credits: ACPE, CME, IACET, PMI, RN
Tracks: Track 19 - SIAC Showcase
Day: Tuesday, Jun, 26
Time: 3:30PM - 4:30PM
Title: Meet the Regulators: Helping You Ensure GCP Compliance by Knowing the Most Frequent and Serious Findings
Event Type: SIAC
Credits: CME, IACET, PMI, RN
Tracks: Track 19 - SIAC Showcase
Day: Tuesday, Jun, 26
Time: 3:30PM - 4:30PM
Title: Navigating the Intersection of Outsourcing and Quality Oversight
Event Type: SIAC
Credits: IACET, PMI
Tracks: Track 19 - SIAC Showcase
Day: Tuesday, Jun, 26
Time: 3:30PM - 4:30PM
Title: New Guidances on Quality Risk Management by FDA and EMA: Implications for Industry
Event Type: SIAC
Credits: CME, IACET, PMI, RN
Tracks: Track 19 - SIAC Showcase
Day: Tuesday, Jun, 26
Time: 3:30PM - 4:30PM
Title: The Future of Project Management in the Pharmaceutical Industry: What Competencies Will Be Critical?
Event Type: SIAC
Credits: IACET, PMI
Tracks: Track 19 - SIAC Showcase
Day: Tuesday, Jun, 26
Time: 3:30PM - 4:30PM
Title: Re-energize Your Career!
Event Type: SIAC
Credits: IACET
Tracks: Track 19 - SIAC Showcase
Day: Tuesday, Jun, 26
Time: 3:30PM - 4:30PM
Title: Rx: A New World in Natural Health Products (NHP)
Event Type: SIAC
Credits: IACET
Tracks: Track 19 - SIAC Showcase
Day: Tuesday, Jun, 26
Time: 3:30PM - 4:30PM
Title: Status of the Use of Electronic Health Records (EHR) in Clinical Research
Event Type: SIAC
Credits: CME, IACET, RN
Tracks: Track 19 - SIAC Showcase
Day: Tuesday, Jun, 26
Time: 3:30PM - 4:30PM
Title: Who Owns the Service? Challenges in Collaboration Between IT and the Business
Event Type: SIAC
Credits: IACET
Tracks: Track 19 - SIAC Showcase
Day: Tuesday, Jun, 26
Time: 3:30PM - 4:30PM

Title: Prescription Drug Marketing Regulatory Primer
Event Type: WORKSHOP
Credits: ACPE, IACET
Tracks: Track 05 - Product Advertising and Marketing
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: Nanotechnology: Regulatory Challenges and Opportunities
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: Implementing Structured Authoring: Understanding the DITA Model and Its Applicability for Content and Metadata Management
Event Type: WORKSHOP
Credits: ACPE, CME, IACET, RN
Tracks: Track 06 - Medical Writing and Medical Communications
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: Environment for Health Care Decision Making: The Role of CER, Evidence-based Medicine, Quality, and Value
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, 27
Time: 8:00AM - 9:30AM
Title: Future Directions for eCTD Module 1
Event Type: SESSION
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: Patient Advocacy in Medical Product Development: The Evolving Relationship Between FDA and Its Patient Stakeholders
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: Clinical Trial Disclosures: A US and EU Regulatory Update
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: Policy and Enforcement Trends: Are Regulators and Industry Heading in the Right Direction?
Event Type: FORUM
Credits: ACPE, IACET
Tracks: Track 10 - Public Policy/Health Care Compliance/Regulatory Law
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: Auditing Pharmaceutical Quality Systems
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 12 - Pharmaceutical Quality
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: Patient Advocacy and Your Next Generation of Research: How Nonprofit Organizations Can Accelerate Product Development
Event Type: SESSION
Credits: IACET
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: Risks to and Securing of Global Drug Supply Chains
Event Type: FORUM
Credits: IACET
Tracks: Track 17 - Global Regulatory
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: Emerging Needs in Clinical Research and Drug Development Sciences Education and Certification
Event Type: SESSION
Credits: IACET
Tracks: Track 16 - Professional Development
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: Risk-sharing Partnerships: Models for Managing Risk across the Clinical-commercial Continuum
Event Type: FORUM
Credits: IACET, PMI
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: FDA and European Medicines Agency Collaboration: GCP Inspections and Beyond
Event Type: SESSION
Credits: IACET
Tracks: Track 11 - Compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Quality Assurance (QA)
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: Active Surveillance Using Large, Electronic Health Care Data Networks
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: Statistical Methods for Analysis of Integrated Safety Data
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: How to Be Prepared for Shifting Regulations on Combination Products
Event Type: SESSION
Credits: IACET
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: Asian Regulatory Agencies Relocated into Biotech Science Park as a Strategy for Global Drug Development
Event Type: SESSION
Credits: IACET
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: Integrating Pharmacogenomics and Companion Diagnostic Development into the Integrated Clinical Development Plan
Event Type: SESSION
Credits: IACET
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: Collaboration and Globalization of Clinical Trials: What Does It Mean to Pharmaceutical Project Managers?
Event Type: FORUM
Credits: CME, IACET, PMI, RN
Tracks: Track 01 - Clinical Operations
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: How Industry Can Partner with FDA in Defining a Risk-based Monitoring Program
Event Type: SESSION
Credits: CME, IACET, PMI, RN
Tracks: Track 01 - Clinical Operations
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: Oncology Medications: State-of-the-art Identification and Management of Potential CV Safety Issues During Development
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 09 - Medical Diagnostics and Devices
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: Combining Patient Self-report and Clinician Oversight: Are Two Heads Better than One?
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: eClinical Interoperability: Imagination, Integration, Implementation
Event Type: SESSION
Credits: IACET
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: Enabling Remote Monitoring in Clinical Trials for Sponsors and Sites
Event Type: SESSION
Tracks: Track 22 - White Paper Showcase
Day: Wednesday, Jun, 27
Time: 8:00AM - 9:30AM
Title: FDA Enforcement Update: Advertising and Promotion
Event Type: SESSION
Credits: ACPE, IACET
Tracks: Track 05 - Product Advertising and Marketing
Day: Wednesday, Jun, 27
Time: 10:00AM - 11:30AM
Title: Natural History Studies for Rare Diseases and Orphan Conditions
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 18 - Rare/Neglected Diseases
Day: Wednesday, Jun, 27
Time: 10:00AM - 11:30AM
Title: Can Human Carcinogenic Risk Be Communicated Without a Rodent Bioassay?
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development
Day: Wednesday, Jun, 27
Time: 10:00AM - 11:30AM
Title: Efficient Regulatory Medical Writing for Global Submissions Including “ICH Outlier” Authorities
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 06 - Medical Writing and Medical Communications
Day: Wednesday, Jun, 27
Time: 10:00AM - 11:30AM
Title: Pursuing Standards to Enhance eCTD Deliverables: PhRMA Electronic Regulatory Submissions (ERS) Group Annual Update
Event Type: FORUM
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Wednesday, Jun, 27
Time: 10:00AM - 11:30AM
Title: Current Advancement of Regulatory Reform for Medical Devices in Asia Pacific and Its Strategic Impact
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 09 - Medical Diagnostics and Devices
Day: Wednesday, Jun, 27
Time: 10:00AM - 11:30AM
Title: Building the Benefit-risk Toolbox: Is There a Consensus on a Scientifically Acceptable Framework?
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Wednesday, Jun, 27
Time: 10:00AM - 11:30AM
Title: Global Product Development: Resolving Conflicting Scientific and Regulatory Advice from Multiple Health Authorities
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Wednesday, Jun, 27
Time: 10:00AM - 11:30AM
Title: Meeting the Therapeutic Needs of Older Patients: A Sustainable Collaborative Approach
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 10 - Public Policy/Health Care Compliance/Regulatory Law
Day: Wednesday, Jun, 27
Time: 10:00AM - 11:30AM
Title: Regulatory Updates on Current Trends in Drug Quality and Manufacturing
Event Type: FORUM
Credits: ACPE, IACET
Tracks: Track 12 - Pharmaceutical Quality
Day: Wednesday, Jun, 27
Time: 10:00AM - 11:30AM
Title: Partnering for Impact in Global Health
Event Type: FORUM
Credits: IACET
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Wednesday, Jun, 27
Time: 10:00AM - 11:30AM
Title: Employee Engagement
Event Type: SYMPOSIUM
Credits: IACET
Tracks: Track 16 - Professional Development
Day: Wednesday, Jun, 27
Time: 10:00AM - 11:30AM
Title: From Adverse Events to Adverse Drug Reactions: Statistical Issues in Safety Labeling
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking
Day: Wednesday, Jun, 27
Time: 10:00AM - 11:30AM
Title: REMS: Are Our Written Communications Truly Mitigating Risks to Patients?
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Wednesday, Jun, 27
Time: 10:00AM - 11:30AM
Title: The Out-Sourcing/In-Sourcing/Out-Sourcing Model for Pharmacovigilance
Event Type: SYMPOSIUM
Credits: IACET
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Wednesday, Jun, 27
Time: 10:00AM - 11:30AM
Title: Project Risk Management Simulation for Product Development
Event Type: WORKSHOP
Credits: IACET, PMI
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Wednesday, Jun, 27
Time: 10:00AM - 11:30AM
Title: Achieving Alignment in a Difficult and Diverse Environment
Event Type: FORUM
Credits: IACET
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Wednesday, Jun, 27
Time: 10:00AM - 11:30AM
Title: Clinical Research in Emerging Regions Around the World
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Wednesday, Jun, 27
Time: 10:00AM - 11:30AM
Title: Applying Longstanding Ethical Principles in a Period of Dynamic Change
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Wednesday, Jun, 27
Time: 10:00AM - 11:30AM
Title: Clinical Outcome Assessments in the Evaluation of Medical Products in Pediatrics
Event Type: SESSION
Credits: ACPE, CME, IACET, PMI, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Wednesday, Jun, 27
Time: 10:00AM - 11:30AM
Title: Identity Management Technologies in Clinical Trials
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Wednesday, Jun, 27
Time: 10:00AM - 11:30AM
Title: Pharmaceuticals and Medical Devices Agency (PMDA) Town Hall
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 17 - Global Regulatory
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: International Advertising/Promotion Coordination
Event Type: SESSION
Credits: ACPE, IACET
Tracks: Track 05 - Product Advertising and Marketing
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: Social Media 2.0: The Power of Online Rare Disease Communities to Connect and Engage ePatients
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 18 - Rare/Neglected Diseases
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: Global Medical Information in Real-life Situations
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 06 - Medical Writing and Medical Communications
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: Microdosing: Past Experience and Future Role in Translational Medicine
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: What Medical Writers Need to Know about MedDRA
Event Type: WORKSHOP
Credits: ACPE, CME, IACET, RN
Tracks: Track 06 - Medical Writing and Medical Communications
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: The Use of Health Technology Assessment (HTA) for Access and Resource Allocation Decision Making: International Examples
Event Type: SYMPOSIUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: Update on Revision of European Medical Device Directives and Impact on Industry
Event Type: SYMPOSIUM
Credits: IACET
Tracks: Track 09 - Medical Diagnostics and Devices
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: Operationalizing SDTM
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: Orphan Drug Development: Global Regulatory Challenges and Initiatives
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: Emerging Development and Policy Trends in the Economics of the Biopharmaceutical Industry
Event Type: SESSION
Credits: ACPE, IACET
Tracks: Track 10 - Public Policy/Health Care Compliance/Regulatory Law
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: Quality Risk Management Workshop
Event Type: WORKSHOP
Credits: IACET
Tracks: Track 12 - Pharmaceutical Quality
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: Functional Service Provider Symposium
Event Type: SYMPOSIUM
Credits: IACET, PMI
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: Thinking Small! A Virtual Pharma Gets Big Work Done with Like-minded Partners
Event Type: SESSION
Credits: IACET, PMI
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: CBER Town Hall
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 17 - Global Regulatory
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: The Changing Face of Clinical Compliance: Regulatory, Technology, and Services
Event Type: SYMPOSIUM
Credits: ACPE, IACET
Tracks: Track 11 - Compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Quality Assurance (QA)
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: Impact of Bayesian Methods in Medical Product Development
Event Type: SESSION
Credits: IACET
Tracks: Track 15 - Statistical Science and Quantitative Thinking
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: Data Sources for Monitoring Usage of Drug Products and How to Use These Sources to Support Safety and REMS Evaluations
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: Drug Development Strategies and Incorporation of an Established Project Management System
Event Type: SESSION
Credits: IACET, PMI
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: Building Clinical Site Capacity for Research
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: Clinical, Statistical, and Data Management Considerations for Developing Clinical Trial Protocols
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: New Regulations and Guidance for Clinical Trials and Human Subject Protection
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: Business Applications in the Cloud
Event Type: FORUM
Credits: IACET
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: Innovations Aimed at Improving Effectiveness and Speed of the Therapeutic Development Process
Event Type: SESSION
Credits: ACPE, CME, IACET, PMI, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: Implementation of Adaptive Clinical Trials
Event Type: SESSION
Tracks: Track 22 - White Paper Showcase
Day: Wednesday, Jun, 27
Time: 1:30PM - 3:00PM
Title: The State of Electronic Submissions at CDER, CBER, and CDRH
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 17 - Global Regulatory
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: Leveraging Drug Development and Advertising/Promotion Regulatory Expertise to Drive a Robust Target Product Profile Process
Event Type: SESSION
Credits: ACPE, IACET
Tracks: Track 05 - Product Advertising and Marketing
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: Rare Disease Clinical Research Consortia: Immediate and Rich Sources of Translational Research Data, Partnering Opportunities
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 18 - Rare/Neglected Diseases
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: Recent Advances in Adaptive Clinical Trial Designs for Medical Writers
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 06 - Medical Writing and Medical Communications
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: The Role of Meta-analyses in Drug Safety: Methodological Considerations
Event Type: FORUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 13 - Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA)
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: Adaptive Licensing: Bane or Boon for Drug Development?
Event Type: SESSION
Credits: IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: Update on Biosimilar Developments in the US
Event Type: SESSION
Credits: ACPE, IACET
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: Emerging Role of the Patient Voice on Drug Policy in Japan
Event Type: SESSION
Credits: ACPE, IACET
Tracks: Track 10 - Public Policy/Health Care Compliance/Regulatory Law
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: Regulatory Capacity Building from 360 Degrees
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 10 - Public Policy/Health Care Compliance/Regulatory Law
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: Effectively Managing Global Trials Within a CRO Alliance Structure
Event Type: FORUM
Credits: IACET, PMI
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: Sites, CROs, and Sponsor Relationship Obstacles and Opportunities
Event Type: SYMPOSIUM
Credits: IACET
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: Learning Through Knowledge Sharing and Virtual Worlds
Event Type: SYMPOSIUM
Credits: IACET
Tracks: Track 16 - Professional Development
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: Good Clinical Practice (GCP) through Good Documentation Practices (GDPs)
Event Type: WORKSHOP
Credits: IACET
Tracks: Track 11 - Compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Quality Assurance (QA)
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: Benefit Versus Risk of Harm: Assessing Therapeutic Response and Interpreting Benefit/Risk with Patients
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, 27
Time: 3:30PM - 5:00PM
Title: Doping Abuse of Medicines in Sport: The Challenge to Industry and Regulators
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: Planning and Execution of a Global Oncology Program
Event Type: SESSION
Credits: IACET
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: Optimizing Study Monitoring Performance and Efficiency
Event Type: SYMPOSIUM
Credits: CME, IACET, PMI, RN
Tracks: Track 01 - Clinical Operations
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: Special Populations Symposium
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: Standard of Care: Challenges for Sponsors, Sites, and Patients in Clinical Trial Budgets
Event Type: SESSION
Credits: IACET
Tracks: Track 01 - Clinical Operations
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: Automation Through CDISC Standard Models: eProtocol, Data Submission, and Safety Reporting
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: Sharing Clinical Data: Examples of What to Share and Benefits to Research and Patients
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: DIA 2013: Helpful Hints in Submitting an Abstract
Event Type: WORKSHOP
Credits: IACET
Tracks: Track 16 - Professional Development
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: India Town Hall
Event Type: FORUM
Credits: IACET
Tracks: Track 17 - Global Regulatory
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: Statistical Comparative Effectiveness Research (CER): Closing the Gaps in the Consideration of Observational Evidence
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 15 - Statistical Science and Quantitative Thinking
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: Biomarker Focused Strategies for Personalized Medicine
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: Implementation of the Physician Payment Sunshine Act: Now What?
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 01 - Clinical Operations;Track 02 - Project/Portfolio Management and Strategic Planning;Track 08 - Regulatory Affairs and Submissions;Track 10 - Public Policy/Health Care Compliance/Regulatory Law;Track 11 - Compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Quality Assurance (QA);Track 21 - Late Breaker
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM
Title: Accelerating Cancer Clinical Trials
Event Type: SESSION
Tracks: Track 22 - White Paper Showcase
Day: Wednesday, Jun, 27
Time: 3:30PM - 5:00PM

Title: CDER Town Hall: Part 1 of 2
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 17 - Global Regulatory
Day: Thursday, Jun, 28
Time: 9:00AM - 10:30AM
Title: Hot Topics Symposium
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development
Day: Thursday, Jun, 28
Time: 9:00AM - 10:30AM
Title: Study Recruitment Challenges, Tailored Medical Information Requests - OH MY! Have You Maximized All Your Options
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 06 - Medical Writing and Medical Communications
Day: Thursday, Jun, 28
Time: 9:00AM - 10:30AM
Title: Multistakeholder Development Partnerships: Harnessing Differing Perspectives, Objectives, and Strengths for Success
Event Type: SYMPOSIUM
Credits: IACET
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Thursday, Jun, 28
Time: 9:00AM - 10:30AM
Title: Integrated Partnership: A Vaccine Case Study
Event Type: FORUM
Credits: IACET, PMI
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Thursday, Jun, 28
Time: 9:00AM - 10:30AM
Title: Left to Your Own Devices
Event Type: SYMPOSIUM
Credits: IACET
Tracks: Track 16 - Professional Development
Day: Thursday, Jun, 28
Time: 9:00AM - 10:30AM
Title: The Role of Corrective and Preventive Action (CAPA) in GCP/GLP Audit Quality Management Systems
Event Type: SYMPOSIUM
Credits: IACET
Tracks: Track 11 - Compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Quality Assurance (QA)
Day: Thursday, Jun, 28
Time: 9:00AM - 10:30AM
Title: Open Source Statistical Software in Drug Development: Challenges and Opportunities
Event Type: SESSION
Credits: IACET
Tracks: Track 15 - Statistical Science and Quantitative Thinking
Day: Thursday, Jun, 28
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, 28
Time: 9:00AM - 10:30AM
Title: Managing Drug Development Portfolios in a Safety-heightened Environment
Event Type: SESSION
Credits: IACET, PMI
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Thursday, Jun, 28
Time: 9:00AM - 10:30AM
Title: Clinical Trial Metrics Symposium
Event Type: SYMPOSIUM
Credits: CME, IACET, PMI, RN
Tracks: Track 01 - Clinical Operations
Day: Thursday, Jun, 28
Time: 9:00AM - 10:30AM
Title: The Cross-over Between Direct-to-patient Studies, Social Media, and EDC
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Thursday, Jun, 28
Time: 9:00AM - 10:30AM
Title: Cloud Computing in Regulated Environments
Event Type: WORKSHOP
Credits: ACPE, CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Thursday, Jun, 28
Time: 9:00AM - 10:30AM
Title: CDER Town Hall: Part 2 of 2
Event Type: FORUM
Credits: CME, IACET, RN
Tracks: Track 17 - Global Regulatory
Day: Thursday, Jun, 28
Time: 10:45AM - 12:15PM
Title: Medical Writing Competencies and Best Practices in the Global Environment
Event Type: SYMPOSIUM
Credits: ACPE, CME, IACET, RN
Tracks: Track 06 - Medical Writing and Medical Communications
Day: Thursday, Jun, 28
Time: 10:45AM - 12:15PM
Title: Strategies for Implementing Dried Blood Spot Drug Development and How the Technology Supports the 3Rs Principles
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 04 - Nonclinical and Translational Development/Early Phase Clinical Development
Day: Thursday, Jun, 28
Time: 10:45AM - 12:15PM
Title: Regulatory Handling of Ethnic Factors in Asian Clinical Trial Data #3, Implication for Simultaneous Global Development (SGD)
Event Type: SESSION
Credits: CME, IACET, RN
Tracks: Track 08 - Regulatory Affairs and Submissions
Day: Thursday, Jun, 28
Time: 10:45AM - 12:15PM
Title: Preferred Provider Relationships: Yesterday’s Obstacles, Today’s Successes, and Tomorrow’s Vision
Event Type: SESSION
Credits: IACET, PMI
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Thursday, Jun, 28
Time: 10:45AM - 12:15PM
Title: Using Technology to Build Successful Strategic Outsourcing Partnerships
Event Type: SESSION
Credits: IACET, PMI
Tracks: Track 03 - Innovative Partnering Models and Outsourcing Strategies
Day: Thursday, Jun, 28
Time: 10:45AM - 12:15PM
Title: Building Rapport and Managing Communication Filters for Breakthrough Collaborations
Event Type: SYMPOSIUM
Credits: IACET
Tracks: Track 16 - Professional Development
Day: Thursday, Jun, 28
Time: 10:45AM - 12:15PM
Title: Increasing Clinical Program Success with Modeling and Simulation
Event Type: SESSION
Credits: IACET
Tracks: Track 15 - Statistical Science and Quantitative Thinking
Day: Thursday, Jun, 28
Time: 10:45AM - 12:15PM
Title: Immunogenicity of Therapeutic Peptides: Regulatory Science Implications
Event Type: SESSION
Credits: ACPE, CME, IACET, RN
Tracks: Track 14 - Clinical Safety and Pharmacovigilance
Day: Thursday, Jun, 28
Time: 10:45AM - 12:15PM
Title: Strategically Reduce Study Cost by Controlling Study Design Cost Drivers, with Attention to Studies with Biomarkers
Event Type: SESSION
Credits: IACET
Tracks: Track 02 - Project/Portfolio Management and Strategic Planning
Day: Thursday, Jun, 28
Time: 10:45AM - 12:15PM
Title: Data Warehousing: Buzz Word or Panacea?
Event Type: SYMPOSIUM
Credits: CME, IACET, RN
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Thursday, Jun, 28
Time: 10:45AM - 12:15PM
Title: Economic Considerations and Management in the Modern Day Clinical Trial
Event Type: SYMPOSIUM
Credits: IACET, PMI
Tracks: Track 07 - Processes and Technologies for Clinical Research
Day: Thursday, Jun, 28
Time: 10:45AM - 12:15PM

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Tuesday, Jun, 26 (90)

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Thursday, Jun, 28 (25)

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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)
Product Advertising and Marketing (Track 05)
Medical Writing and Medical Communications (Track 06)
Processes and Technologies for Clinical Research (Track 07)
Regulatory Affairs and Submissions (Track 08)
Medical Diagnostics and Devices (Track 09)
Public Policy/Health Care Compliance/Regulatory Law (Track 10)
Compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), 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)
Global Regulatory (Track 17)
Rare/Neglected Diseases (Track 18)
SIAC Showcase (Track 19)
Executive Program: Pioneering Partnerships (Track 20)
Late Breaker (Track 21)
White Paper Showcase (Track 22)

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Sunday, Jun, 24 (15)

Monday, Jun, 25 (77)

Tuesday, Jun, 26 (90)

Wednesday, Jun, 27 (98)

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