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Monday, June 19
 

6:30am

7:00am

7:30am

8:30am

10:00am

10:15am

11:00am

#130: Career Opportunities in Transitions in Life Science S400 Concourse #106: Leveraging Big Data/ Real-World Data in Enabling Efficient and Data-Driven Clinical Research From Sponsor, Vendor and National Health System Perspective: Case Studies N229 #107: Leveraging Wearables and Sensors in Clinical Trials and mHealth S501abc #108: Artificial Intelligence/Machine Learning S502ab #109: Submission Dossiers: Communications Excellence to Drive Speed and Quality S503ab #110: Globalization of Medical Affairs Departments S504abc #111: Patient Engagement: 4 W's and an H N426a #112: Data Sharing: 2017 and Beyond N426b #113: We Can't Forget the Children in This Process N426c #114: PDUFA at 25: A Historical View of the Prescription Drug User Fee Agreement and a Look to the Future - PDUFA VI N228 #117: Postmarketing Safety Studies: Approaches and Regulatory Insights S401a #118: Counting on Safety S401d #119: Designing and Implementing a Robust Pharmacovigilance System for Vaccines S401bc #120: FDA Rare Disease Town Hall N227b #121: Effective Life Cycle Management S505ab #122: GBM AGILE: A Transformative Global Adaptive Platform Clinical Trial S404a #123: Calling All Angels to the Valley of Death S405b #124: Exploration of PK/PD in NDA Enabling or Early Proof of Concept Studies S402ab #125: Hybrid Study Designs: An Innovative Approach to Obtaining Valuable Information by Combining Existing Data with New Data Length S404bc #126: Breaking Down the Wall for FDA to Leverage Real World Data N226 #127: The Evolving International Landscape of FDA Inspections: Data Integrity Violations in Bioequivalence Studies in India S405a #128: Office of Pharmaceutical Quality Update: Innovative Approaches in Regulatory Assessment N230b #129: Engage and Exchange Student Forum Exhibit Hall #115: Update from the CFDA S403ab

11:45am

12:00pm

12:30pm

1:00pm

1:15pm

1:45pm

2:00pm

3:00pm

4:30pm

4:45pm

5:30pm