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Wednesday, June 29

7:00am EDT

8:00am EDT

9:00am EDT

9:30am EDT

9:40am EDT

9:45am EDT

10:30am EDT

#320: Design Thinking to Redesign the Clinical Trial Business Model and Improve Efficiency and Quality of Clinical Trials 201A #312: Human Tissue Models: A Look into the Future of Safety Pharmacology Studies 113C #314: Transforming Clinical Protocols into a Digital Platform: Driving Quality and Efficiency End-to-End 203AB #318: Changes to Common Rule Likely Affecting FDA-Governed Research 202AB #322: Real-World Evidence in Drug Development: Creating the Right Environment for Enhanced Pre-Launch Evidence 107AB #327: FDA–Health Canada Regulatory Cooperation Council Town Hall 201C #307: Mythbusting Site Productivity: Referral Practices and Untapped Site Options 108A #308: Patient Recruitment Workshop: Survey Results and Practical Application 102AB #310: Bridging CMC and Project Management to Achieve High Quality Product Submissions and Launch 108B #309: Global Stakeholder Management: Across the Ocean Between East and West 105AB #311: Outsourcing: Assessing CRO Performance and Challenges 111AB #313: The Future of Clinical Research Data: 2020 and Beyond 204B #315: Enhancing Pediatric Product Development in a Global Regulatory Environment: Extrapolation and Modeling and Simulation, Oh My! 201B #316: What’s Your Preference? The Emerging Importance of Patient Preference Elicitation 204C #317: Global Medical Device Development: Regulatory Concordance or Discordance? 103C #319: Unlocking the Mysteries of Knowledge Management and Potential Applications for Clinical Development 204A #321: Office of Pharmaceutical Quality Update 113B #323: Social Listening for Pharmacovigilance: Practical Considerations and Challenges for Implementation 113A #324: Implementing Adaptive Designs Involves Greater Teamwork 109AB #325: Reinventing You: How to Change Your Career Fearlessly! 112AB #326: FDA Rare Disease Town Hall 103A

10:45am EDT

11:30am EDT

12:00pm EDT

12:40pm EDT

1:20pm EDT

1:30pm EDT

2:00pm EDT

#341: eTMF: Selection, Implementation, and What's Next? 204B #351: Emergent Study Designs and Analysis Methods Addressing Issues Associated with Pediatric Clinical Studies 108B #353: The Utility of Natural History Studies in Drug Development and Approval 103C #354: Protocol Optimization: Making It Real Exhibit Hall A #333: Hearing the Patient Voice in Pharma and What Patients Want You to Know 113A #334: Risky Business: Latest Trends, Strategies, and Tools for Predicting Success and Monitoring Risk During Clinical Trial Operations 113B #335: Multi-Ethnic, Special Populations, and Patient Diversity in Clinical Trials 113C #336: Effect of International Reference Pricing on Planning for Global New Product Launches 105AB #337: Overcoming Deficiencies in the Oversight of Outsourced Clinical Programs: Collaboration and Utilization of Industry Leading Guidelines and Tools 112AB #338: Evolving Methods in Pain Trials: Evaluating Abuse Deterrence, Drug Interactions, and Appropriate Patient Selection 201A #339: Evolution of Patient Safety Reporting: PSURs to RMPs, Challenges, and How to Face Them 203AB #342: Big Data in Health Care and Life Sciences 201C #340: eSource: Using Source Data Capture from Electronic Health Records to Improve Clinical Research 204C #343: Strategies, Enablers, and Barriers to Medicine Development in the Emerging Markets: The 2025 Global Regulatory Landscape 201B #344: Companion Diagnostics: Driving New Business Models for Successful Outcomes 103A #345: Are State Consumer Fraud Lawsuits Encroaching on FDA’s Regulatory Authority? 202AB #346: Anticipating and Responding to Challenges in Issue Management 204A #347: Global Harmonization: Non-ICH Regions 111AB #348: Interpreting Meaningful Change on PROs: When to Talk, When to Use Cumulative Distribution Functions, and When to ROC 107AB #349: Measuring the Effectiveness of Risk Minimization: Principles and Regional Requirements 109AB #352: From Mistakes to Success: Lessons Learned from Organizational Change Management Programs 102AB #350: Evaluating the Impact of Adverse Event Information from Solicited Programs on Benefit-Risk Profiles: Is It Worth the Effort? 108A

3:00pm EDT

3:15pm EDT

3:25pm EDT

4:00pm EDT

#360: Biomarkers and Sample Stability: Bottlenecks in Study Planning, Ensuring Sample Stability as the Key for Reliable Lab Results 105AB #361: Protocol Endpoints: A Clear Map to Navigate the Yellow Brick Road and the End of Endpoint-Creep 203AB #367: Quality at the Edge(s): Design It Right and Keep It Going in Non-Interventional Studies 204A #368: Conducting Trials in China 201A #372: Impact of the European Medicines Agency’s Medical Literature Monitoring Service on Pharmacovigilance Processes 113C #371: FDA and PatientsLikeMe: Exploring the Use of Patient-Generated Data in Drug Safety 113A #374: Design and Execution of Futility Analysis Using Real-World Case Studies: Key Considerations 108A #375: Creating Competent Clinical Research Professionals Through Systematic Evidence Review 112AB #357: The Internet of Things and Clinical Research: Privacy, Security, and Ethical Aspects 108B #358: Don’t Shoot the Messenger: Techniques for Delivering the Hard Messages 102AB #359: Addressing Dysfunction in Provider Prequalification: A New Model to Streamline Processes, Improve Quality, and Reduce Risk 111AB #362: Risk-Based Monitoring: Best Practices in Implementation for the Data Manager and Key Stakeholders 204C #363: Expedited Reviews and Other Pathways to Speed Up Access to Medicines 201B #364: Cell and Gene Therapies: Current Global Landscape 204B #365: Cross-Labeling of Drugs and Devices: How Can It Be Done? 103A #366: Infectious Disease Containment and Lessons Learned 202AB #369: Innovative and Emerging Technologies 109AB #370: Pricing, Patient Access, and What’s Next for Today’s Biopharma and Devices 107AB #373: Safety Reporting Pitfalls and Successes for Oncology and Hematology Drugs 113B #376: Pediatric Rare Disease Drug Development 103C