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LEVEL: Intermediate [clear filter]
Sunday, June 14
 

9:00am EDT

12:30pm EDT

2:30pm EDT

 
Monday, June 15
 

8:00am EDT

11:00am EDT

1:30pm EDT

3:30pm EDT

 
Tuesday, June 16
 

8:00am EDT

9:30am EDT

11:30am EDT

2:00pm EDT

4:00pm EDT

 
Wednesday, June 17
 

8:00am EDT

9:30am EDT

11:30am EDT

2:00pm EDT

4:00pm EDT

 
Thursday, June 18
 

8:00am EDT

9:30am EDT

11:30am EDT

5:00pm EDT

#501 OD: ON DEMAND - Advancing Risk Management: What Can Evidence-Based Practices to Disseminate Healthcare Evidence into Practice Teach Us? TBD #503 OD: ON DEMAND - MedDRA® Labeling Groupings for Enhanced Communication of Safety Concepts: Cinderella’s Glass Slipper? TBD #504.1 OD: ON DEMAND - The Opioid Epidemic: Top Ten Lessons in Regulatory Science TBD #505 OD: ON DEMAND - Older People Can’t Use ePRO and Other Industry Myths: An Interactive Debate TBD #506 OD: ON DEMAND - The Power of Real World Data and the Innovative Approaches for Usage TBD #507 OD: ON DEMAND - Managing Global Clinical Trials in Emerging Regions: Latin America 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 #516 OD: ON DEMAND - Deploying Machine Learning in Data Management TBD #519 OD: ON DEMAND - Applying the Concepts of Good Clinical Practice in Real World Evidence 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 #530 OD: ON DEMAND - The DEEP Model: Long-Term Commitment to Partnering With Patients TBD #532 OD: ON DEMAND - Setting a Strategic Foundation for Mutually Beneficial Collaborations Between Industry and Patient Organizations TBD #529 OD: ON DEMAND - Impact Patient Centered Initiatives in Clinical Trial Design and Execution TBD #528 OD: ON DEMAND - Communicate and Co-Create with Patients Across the Medicines Development Lifecycle: Principles and Best Practices 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 #540 OD: ON DEMAND - Recipe for Transformation to Higher-Performing Teams TBD #542 OD: ON DEMAND - Impact of Advanced Data Analytics Capabilities on Quality and Compliance Activities: Overview and Case Studies TBD #543 OD: ON DEMAND - Opportunities and Challenges for ICH E6 (GCP) Renovation 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 #553 OD: ON DEMAND - What Makes Real World Data Trustworthy: A Focus on Design and Data TBD #554 OD: ON DEMAND - Strengthening Food and Drug Regulatory Systems Abroad: Recommendations from the FDA-Commissioned NASEM Report TBD #555 OD: ON DEMAND - Updates of Drug Evaluation and Inspection in China TBD #558 OD: ON DEMAND - Quality Considerations for Complex Drugs TBD #559 OD: ON DEMAND - Replication of Randomized Controlled Trials Using Real World Data: What Does Good Look Like? TBD #560 OD: ON DEMAND - Using Data Visualization to Drive Meaningful Insights 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 #565 OD: ON DEMAND - Considerations for Long-Term Outcomes Data Collection for Value-Based Payment Arrangements TBD #566 OD: ON DEMAND - Subscription Models to Incentive Antimicrobial Innovation TBD #567 OD: ON DEMAND - Real World Use of Real World Evidence TBD #570 OD: ON DEMAND - Networking for Everyone: Extrovert/Introvert/Centrovert TBD