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Thursday, June 18
 

8:00am EDT

#401 L: Digital Risk Minimization: How Can We Advance Adoption? TBD #403 L: Best Practices in Developing Medical Information Responses TBD #406 SL: FDA-PAHO: Landscape Report of Regulatory Situation in the Americas TBD #405 L: Catalyzing the Integration of Digital Technologies in Healthcare Solutions TBD #410 SL: Statistical Considerations for Using External Controls in Clinical Trials TBD

9:30am EDT

#413 L: Orphan Drug Development in Personalized Medicine TBD #414 SL: ICH 30th Anniversary Series: International Harmonization for Pharmaceutical Quality TBD #415 SL: Opportunities and Challenges for Real World Data and Real World Evidence: Dive Into the Details TBD

11:30am EDT

#423 L: Reusing What You Wrote the First Time: Deja Vu All Over Again TBD

5:00pm EDT

#502 OD: ON DEMAND - Unblinding The New Face of the Local Safety Officer TBD #504.1 OD: ON DEMAND - The Opioid Epidemic: Top Ten Lessons in Regulatory Science TBD #506 OD: ON DEMAND - The Power of Real World Data and the Innovative Approaches for Usage TBD #508 OD: ON DEMAND - Optimizing Study Start Up Processes: Site Selection, Budgeting, and Contracting TBD #510 OD: ON DEMAND - Journey of TMF Reference Model in Driving Inspection Readiness: The Decade's Impact, the Evolution to Come TBD #511 OD: ON DEMAND - Design and Implementation of Multiregional Clinical Trials (MRCT) Using ICH E17 Guidelines TBD #512 OD: ON DEMAND - Pediatric Clinical Trial Design and Ethical Considerations: Understanding Prospect of Direct Benefit and Risk TBD #513 OD: ON DEMAND - Templates That Do More: How We Are Accelerating Drug Development via Structured Content Reuse TBD #514 OD: ON DEMAND - Single-Sponsor Master Protocol: Development and Regulatory Experience with a Complex Innovative Design (CID) TBD #515 OD: ON DEMAND - Artificial Intelligence: Use Cases from Real Trials TBD #518 OD: ON DEMAND - Advancing Clinical Research Through Fast Healthcare Interoperability Resources: An Industry Perspective of Where We Are and Where To Go TBD #519 OD: ON DEMAND - Applying the Concepts of Good Clinical Practice in Real World Evidence TBD #520 OD: ON DEMAND - Wearables TBD #521 OD: ON DEMAND - Data Related International Policy and Strategy: EVDAS, E2B (R3), GDPR TBD #522 OD: ON DEMAND - Online Medical Information Resources and Channels TBD #524 OD: ON DEMAND - Storyboarding for Key Message Alignment in Marketing Applications TBD #526 OD: ON DEMAND - Assessing the Adoption of Clinical Trial Results Summary Disclosure to Patients and the Public TBD #527 OD: ON DEMAND - Patient Preferences in the Medical Product Lifecycle: Evolving Uses, Stakeholder Considerations, and Applications TBD #529 OD: ON DEMAND - Impact Patient Centered Initiatives in Clinical Trial Design and Execution TBD #533 OD: ON DEMAND - Phase 1 Cell and Gene Therapy Research: Special Considerations for CMC, Regulatory Approvals, and Site Preparation TBD #534 OD: ON DEMAND - Bridging Bench to Bedside With Novel Biomarkers TBD #535 OD: ON DEMAND - Developing Products by the FDA Animal Rule: Working with FDA and Real World Challenges TBD #536 OD: ON DEMAND - Microbiome Therapies Beyond Fecal Microbiota Transplantation: Challenges and Opportunities TBD #537 OD: ON DEMAND - Combination Therapies of Investigational Agents TBD #538 OD: ON DEMAND - Project Management Playbook to Effective Stakeholder Management TBD #539 OD: ON DEMAND - Revolutionizing Project Management Through Building Your Culture and Emotional Intelligence TBD #540 OD: ON DEMAND - Recipe for Transformation to Higher-Performing Teams TBD #544 OD: ON DEMAND - Pharmacovigilance Inspections: Leveraging Inspection Intelligence as a Driver of Quality in Your Organization TBD #545 OD: ON DEMAND - Clinical Safety: Approaches to Assure Compliance in the Pharmacovigilance and GCP Interface TBD #546 OD: ON DEMAND - Quality Oversight of Pharmacovigilance Processes TBD #541 OD: ON DEMAND - Electronic Informed Consent: Global Perspectives TBD #550 OD: ON DEMAND - PMDA Town Hall: The Path of a New Chief Executive Since His Appointment TBD #552 OD: ON DEMAND - Regulatory Barriers to Entry for Biosimilars TBD #556 OD: ON DEMAND - Demystifying Global Device Requirements: High Level Comparison of Current Expectations TBD #557 OD: ON DEMAND - N-Nitrosamines Contamination Case Lessons Learned TBD #558 OD: ON DEMAND - Quality Considerations for Complex Drugs TBD #560 OD: ON DEMAND - Using Data Visualization to Drive Meaningful Insights TBD #561 OD: ON DEMAND - Hype or Hope: Quantifying the Risk of Patients with Complex Diseases TBD #562 OD: ON DEMAND - Utilization of Bayesian Statistics in Clinical Trials TBD #563 OD: ON DEMAND - Best Practices for Randomization and Re-Randomization in Clinical Trials TBD #564 OD: On DEMAND - Communicating Value to Payers Pre-Approval in the US TBD #567 OD: ON DEMAND - Real World Use of Real World Evidence TBD #571 OD: CRO Leadership Awards TBD