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Tuesday, June 27
 

8:00am EDT

8:30am EDT

9:30am EDT

9:45am EDT

10:30am EDT

#216: Benefit-Risk Balance for Medicinal Products: CIOMS Working Group XII Report Room 205 BC #217: Good Recruitment Practice Under Regulation (EU) No 536/2014 Room 254 #218: The Future of Regulatory Submissions: Opportunities and Challenges Room 206 #224: Time for Alignment? A Policy Landscape Update on the Use and Acceptance of Real-World Data/Real-World Evidence for Regulatory Purposes Room 153 AB #229: The Full Picture: Innovative Software Tools for Data Insight Generation and Exploration Room 102 #219: Medical Storytelling Inserted Into All Aspects of Medical Affairs Room 253 C #220: Disrupting the Status Quo: Best Practices for Bringing Together Patients and Medical Staff to Positively Impact Trial Diversity Room 205 A #221: The Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP) Collaboratory: Facilitation of Medical Product Development for Rare Diseases Room 252 #222: How to Make Good Decisions Quickly Room 204 #223: One Year On: How Quality Briefs are Transforming the Approach to Quality and Driving Innovation to Serve Patients Room 253 B #227: ANVISA Town Hall Room 253 A #225: Post-Pandemic Regulatory Innovation for Clinical Trials and Opportunities for Global Alignment Room 156 #226: Patient Experience Data in the Label: Closing the Loop Room 157 AB #228: A Regulatory Pharmaceutical Quality Knowledge Management System to Improve the Availability of Quality Medicines Room 151 #230: Is Mark Cuban Really Solving the Drug Pricing Problem? Room 104 AB

10:45am EDT

11:30am EDT

11:45am EDT

11:50am EDT

12:30pm EDT

1:15pm EDT

#242: Novel Methods for Signal Identification for Medicines and Medical Devices Room 205 BC #244: Meta-Collaboration to Improve Decentralized Trial Excellence: Updates from the Collaboration Landscape Room 254 #243: Hot off the Press: Site Challenges and Solutions in Workforce and Technology Room 253 A #245: Global Regulatory Perspectives About Real-World Data: DARWIN EU®, FDA, and Other Current Initiatives Room 206 #253: Quality in the Real World: Identifying and Addressing Inaccuracies and Gaps in Routinely Collected Patient Data Room 102 #246: Tech-Enabled Narratives: Technology Meets Process FTW (For the Win!) Room 253 C #247: Measuring Impact of Patient Engagement Across Research and Development Room 205 A #248: Agile Project Management Practitioners Tackle Challenges Within the Life Sciences Room 204 #255: Future- Proofing your Career: The Essential Guide for all Things Legal and Venture Capital for Biopharma Professionals Room 252 #249: Pharmacovigilance: Regulator's Perspectives on Quality Approaches to Additional Risk-Minimization Measures and Post-Pandemic Inspection Reflections Room 253 B #251: Asia Town Hall Room 153 AB #250: Implementing Digital Health Technologies in Clinical Trials: How to Apply New Resources to Address Key Questions Room 156 #252: One Dossier and One Timeline for a Post Approval Change: The Story of a Regulatory Reliance Pilot! Room 151 #254: The Inflation Reduction Act Price Setting: What are the Impacts on Biopharmaceutical Innovation from Different Perspectives? Room 104 AB

2:15pm EDT

2:30pm EDT

2:35pm EDT

3:00pm EDT

3:15pm EDT

4:00pm EDT

 

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