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Venue: Room 185 AB [clear filter]
Monday, June 20
 

1:30pm CDT

#120: Practical Applications of the Estimand Framework in Novel, Complex Settings Room 185 AB

4:00pm CDT

#138: ICH E8(R1): Regulators' Perspectives on Quality-by-Design of Clinical Studies Room 185 AB
 
Tuesday, June 21
 

9:15am CDT

#212: Where Are We with Antimicrobial Resistance (AMR) in the Regulatory Space? Room 185 AB

11:15am CDT

#229: Accelerating Cell and Gene Therapy Development Through International Regulator Collaboration Room 185 AB

2:00pm CDT

#253: Efforts to Improve Diversity of Clinical Trial Participants Room 185 AB

4:15pm CDT

#277: Quantitative Benefit-Risk Approaches in Drug Development and Approval: Examples from FDA and Industry Room 185 AB
 
Wednesday, June 22
 

9:15am CDT

#310: BsUFA III and GDUFA III: Increasing FDA’s Authority to Enhance Competition Room 185 AB

11:15am CDT

#327: New Approaches to Inspections Room 185 AB

2:00pm CDT

#348: Research and Innovation to Enhance Patient Access to Topical Dermatological Products in the US Room 185 AB

4:15pm CDT

#370: Where Are we Really on Data Interoperability? Room 185 AB
 
Thursday, June 23
 

10:00am CDT

#409: How to Build and Support a Culture that Values Critical Thinking and Open, Proactive Dialogue About Quality Room 185 AB
 
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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
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Room 183 A
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Room 185 AB
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Room 375 A Zone 1
Room 375 A Zone 2
Room 470 A
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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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  • Featured Topics
  • AI and Machine Learning
  • COVID-19
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  • Innovative Trial Design
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  • Remote Work
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