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Monday, June 20
 

1:15pm CDT

#112: ICH Q2 (R2) and Q14: Can We Realize the Vision for Risk-Based Approvals of Analytical Procedures and Changes? Room 180

4:00pm CDT

#133: New Tools for Creating Flexible and Sustainable Master Protocols Room 176 #140: ICMRA: COVID-19 Response and International Collaboration Room 184
 
Tuesday, June 21
 

11:15am CDT

#227: Approaching the Assessment of Clinical Protocol Complexity Room 183 C

4:15pm CDT

#268: Life Science Research Innovation Powered by Real-World Data Room 183 A #269: Strategic Planning in Selecting the Right Countries and Sites for Clinical Trials Room 183 C #270: Recommendations for Conducting Bring Your Own “Device” (BYOD) Clinical Studies Room 180 #276: Rethinking Fundamental ICH CMC Guidelines: Analytical Procedures, Stability, Specifications, and Risk Assessment Room 176 #277: Quantitative Benefit-Risk Approaches in Drug Development and Approval: Examples from FDA and Industry Room 185 AB
 
Wednesday, June 22
 

2:00pm CDT

#353: Planning for the Worst: Approaches for Drug Shortage Avoidance Room 183 B

4:15pm CDT

#376: How to Manage Device Design Changes Under EU MDR Room 183 C #377: Choosing the Most Convincing Clinical Endpoints in Cancer Clinical Trials: How to Balance Different Perspectives? Room 470 B
 
Monday, June 26
 

1:30pm CDT

Do Surrogate Endpoints Expedite or Hinder Payer Coverage of Drugs? TBD

4:15pm CDT

Enabling the Use of Randomized Pragmatic Studies to Generate High Quality Real-World Evidence for Regulatory Decisions TBD One Year On: How Quality Briefs are Transforming the Approach to Quality and Driving Innovation to Serve Patients TBD Challenges in Analytical Development of Cell and Gene Therapy Products, Regulatory Perspectives, and Convergence TBD
 
Tuesday, June 27
 

8:30am CDT

Ethical Considerations for Conducting Research During Times of Disruption TBD Innovating Patient Recruitment Through Pharmacy Channels TBD

10:30am CDT

A Regulatory Pharmaceutical Quality Knowledge Management System to Improve the Availability of Quality Medicines TBD Is Mark Cuban Really Solving the Drug Pricing Problem? TBD

1:15pm CDT

Using Artificial Intelligence to Illuminate Predictive Relationships and Discover Biomarkers from Clinical, Molecular, and Digital Data TBD

4:00pm CDT

Data Analytics for Quality Assurance: Shifting the Paradigm from Issue Detection to Quality Evidence Generation TBD Patient-Preferences and Multistate Models to Enhance Patient-Focus of Traditional Endpoints in Oncology TBD
 
Wednesday, June 28
 

1:15pm CDT

The Future of Biosimilar and Interchangeable Biologics: Global Development, Harmonization, and the Inflation Reduction Act TBD

4:00pm CDT

From 1000's of Tables to Summarizing Clinical Trials Graphically TBD
 
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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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