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Wednesday, June 19
 

7:00am PDT

8:00am PDT

#301: Risk Minimization in the EU: New Guidance, New Collaborations Room 11AB #303: How Common Data Models Can Address the Challenges in the Use of Clinical Trial and Real-World Data for Evidence Generation Room 6D #304: Synergizing Large Language Models and Digital Health Technology for Healthcare Transformation Room 6E #305: All the Ways Medical Affairs Supports Product Development: From Clinical Trials to Product Launch Room 7AB #306: Which Clinical Outcome Assessment to Choose: Questionnaire or Sensor? Time to Align an Endpoint Selection Framework Room 15AB #302: Have a Safe Trip: Clinical and Patient Alignment in Clinical Trials with Psychedelics Room 6A #308: Unlocking Innovation: Implementing Future-Focused Risk-Based Quality Management Quality Briefs - A Cross-Functional Challenge Room 8 #309: FDA Oncology Center of Excellence: Are Sponsors Taking Full Advantage of OCE Regulatory Policy “Projects?” Room 6F #310: WHO Town Hall: Safeguarding Public Health - WHO's Vision for Global Regulatory Excellence Room 1AB #311: Australia, Canada, Singapore, Switzerland, and United Kingdom Consortium (Access): Re-Imagining Regulatory Collaboration Room 6B #307: Partnering with Regulatory Authorities to Unlock the Value in Digital Health Products Room 2 #312: Revolutionizing Regulatory CMC and Advanced Manufacturing with the Power of AI: Unleashing Innovation and Efficiency Room 6C #313: The Future of Women’s Health: Do We Really Want Innovation? Policy Ideas To Advance Innovation, Access, and Novel Approaches Room 5AB

9:00am PDT

9:15am PDT

10:00am PDT

11:00am PDT

11:15am PDT

11:45am PDT

12:30pm PDT

1:15pm PDT

2:15pm PDT

2:30pm PDT

3:15pm PDT

4:30pm PDT

 

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