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Wednesday, June 21

10:30am CDT

2:00pm CDT

4:00pm CDT

#373: FDA–Health Canada Regulatory Cooperation Council Town Hall S401d #363: EHRs/eSource and Emerging Data Streams N230b #364: Risk-Based Monitoring: Convergence of Technology, Processes, and People: Panel Discussion N226 #365: Next Generation Predictive Analytics S503ab #366: Are We Ready for Telemedicine-Powered Clinical Trials? S504abc #367: Writing of Layperson Summaries of Clinical Trial Results According to the EU: Regulation and Its Impact on Global Pharmaceutical Activities S502ab #368: FDA Update on Prescription Drug Promotion N227b #369: How Is Digital Patient Engagement Impacting Trial Participation? S404a #370: Lessons Learned from the Sarepta Exondys 51 Approval S404bc #371: Global and Regional Collaboration Initiatives: Challenges, Opportunities, and Case Studies S403ab #372: The Reauthorization of GDUFA and Its Impact on Sponsor and Regulator N229 #374: Global Perspective on ICH: Part 2 of 2 N228 #375: Automation and Innovation in Clinical Trial Safety Assessment S402ab #376: Changing Environments Within Pharmacovigilance S404d #377: Increasing Participation in Clinical Trials Among Under-Represented Populations S505ab #378: Looking to the Future for EU Pediatric Investigation Plans S501abc #381: Maximizing Success in Partner Collaborations N426b #382: Patient-Relevant, Fit-For-Purpose Endpoints: If You Can Believe It, You Can Achieve It S405a #383: Safety Issues in First-in-Human Studies S405b #384: The Increasing Role for Big Data for Late Phase Drug and Postapproval Purposes S401a