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Monday, June 20
 

1:30pm CDT

#116: Incorporating Patient Experience Data in Global R&D Room 183 A

4:00pm CDT

#131: Innovations for Implementing REMS Room 185 CD #134: FDA Update on the Upcoming PDUFA VII Data and Technology Commitment Room 178 #138: ICH E8(R1): Regulators' Perspectives on Quality-by-Design of Clinical Studies Room 185 AB #140: ICMRA: COVID-19 Response and International Collaboration Room 184 #139: FDA and EMA Benefit-Risk Assessments: Can We Optimize and Is There an Enhanced Role for Sponsors and Patient Preferences? Room 187
 
Tuesday, June 21
 

9:00am CDT

#201: Transforming PV at the MHRA Room 175

9:15am CDT

#209: New EU Clinical Trial Regulation: Experience So Far Room 184

11:00am CDT

#224: ICMRA Update: Convergence and Collaboration on COVID-19 - Learning from the Present for the Future Room 179

11:15am CDT

#230: Asia Town Hall Room 186

1:45pm CDT

#241: Drug Safety in Africa: New PV Horizons Room 178 #242: Risk Minimization for Health Products: What are we Learning for an Improved Path Forward Room 175

2:00pm CDT

#250: Patients as Central Partners in COA Design Room 183 C #252: International Collaborations: What’s New in Oncology? Room 184

4:15pm CDT

#266: FDA's Updates on Ensuring Post Market Safety and Surveillance for Generic Drugs Room 178 #275.1: PMDA Town Hall Room 183 B #277: Quantitative Benefit-Risk Approaches in Drug Development and Approval: Examples from FDA and Industry Room 185 AB
 
Wednesday, June 22
 

9:15am CDT

#309: Pharmacovigilance Quality: Key Considerations Room 187 #311: Ahead of Analyses: Planning, Designing, and Pre-Specifying Observational Studies Room 185 CD #312: COVID-19 360°: Embedding Global Best Practices in Routine Regulatory Action and Preparing for the Next Pandemic Room 184 #313: China Town Hall Room 186

11:00am CDT

#318: Rare Disease Data Sharing: A Value Proposition Room 178 #323: Remote GMP Assessments, Inspections and Audits : Here to Stay? Room 186

11:15am CDT

#324: The Value of Medical Writing: The Regulator's Perspective, Development of Professional Medical Writers as Successful Leaders Room 183 C #327: New Approaches to Inspections Room 185 AB #328: Approaches to Health Authority Collaboration: Are They Fit-for-Purpose and How Should They Evolve Post-Pandemic? Room 183 B #329: Complex Innovative Design: What’s in Name? A Global Perspective on the Changing Design Landscape Room 185 CD #330: Leveraging Real-World Evidence to Address Diversity Gaps in Randomized Clinical Trials: Regulatory, Clinical, and Other Considerations Room 184

1:45pm CDT

#340: Monitoring COVID-19 Vaccine Safety Room 178

2:00pm CDT

#348: Research and Innovation to Enhance Patient Access to Topical Dermatological Products in the US Room 185 AB #351: Health Canada Town Hall Room 183 A #352: FDA Rare Disease Town Hall Room 187

4:15pm CDT

#365: Field of Dreams: If We Build it, Will they Come? Using Implementation Science to Improve Digital Risk-Minimization Tools Room 175 #366: Development of Standard Core Sets of Clinical Outcome Assessments and Related Endpoints Room 178 #374: Around the World: Regulator Perspectives on Decentralized Clinical Trials Room 184 #375: The Global Impact of ORBIS: Case Studies and Perspectives Room 187 #377: Choosing the Most Convincing Clinical Endpoints in Cancer Clinical Trials: How to Balance Different Perspectives? Room 470 B
 
Thursday, June 23
 

10:00am CDT

#404: Combination Product Safety: A Journey of Organizational Transformation Room 175 #411: FDA Oncology Center of Excellence’s Real-Time Oncology Review Program: 2022 Update Room 183 A #415: EMA-FDA Question Time Room 184

11:30am CDT

#416: FDA Town Hall Room 184
 
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Exh Hall Community Area
Exhibit Hall
Exhibit Hall Booth #1719
Exhibit Hall Theater #1
Exhibit Hall Theater #2
Exhibit Hall Theater #3
Level 3 F2 Entrance
Meeting Rm Lobby Level 1
Meeting Room Lobby
Room 175
Room 176
Room 178
Room 179
Room 180
Room 183 A
Room 183 B
Room 183 C
Room 184
Room 185 AB
Room 185 CD
Room 186
Room 187
Room 375 A Zone 1
Room 375 A Zone 2
Room 470 A
Room 470 B
Room 471 A
Room Skyline 375 CDE
Skyline Ballroom Foyer
TBD
Virtual
  • 00: Plenary
  • 01 - Clinical Safety and Pharmacovigilance
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Tech in Clinical Trials
  • 04: MedAffairs-SciComm
  • 05: Patient Engagement
  • 06: PreClinical Dev-EarlyPhaseCR
  • 06 - Translational Sciences and Precision Medicine
  • 06: TranslationalScience-PrecisionMedicine
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics
  • 12: Value-Access
  • 13: ProfDevelopment
  • 14: DIAmond
  • 15: Content Hubs
  • 16: Community Rounds
  • 17: Networking Opportunities
  • 18: Posters
  • 19: InnovationTheaters
  • 20: Short Courses
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  • Intermediate
  • Featured Topics
  • AI and Machine Learning
  • COVID-19
  • Data Science
  • Decentralized Trials
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  • Diversity Equity and Inclusion
  • Innovative Trial Design
  • Patient Perspective
  • Personalized Health Care
  • Regulator Perspective
  • Remote Work
  • RWD-RWE
  • Special Populations
  • Student Programming