Loading…
This event has ended. Visit the official site or create your own event on Sched.

Sign up or log in to bookmark your favorites and sync them to your phone or calendar.

←View All Dates
Wednesday, June 29
 

7:00am

8:00am

9:00am

9:30am

9:40am

9:45am

10:30am

#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

11:30am

12:00pm

12:40pm

1:20pm

1:30pm

2:00pm

#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

3:15pm

3:25pm

4:00pm

#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