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Wednesday, June 22
 

9:00am CDT

#301: Uses of Artificial Intelligence for PV in the Context of COVID 19 Room 178 #304: Transformation of the Data Manager to the Data Scientist Room 470 B #305: What’s New at ICH? From the E11A Pediatric Extrapolation Guideline to Model Informed Drug Development (MIDD) Room 175 #306: Leveraging Best Practices and Tools from the Discipline of Project Management to Uphold Quality, Protect Patient Safety, and Optimize Financial Budgets in a World of Complexities Room 183 C

9:15am CDT

#308: Community and Patient Engagement: Putting Research into Context Room 183 B #309: Pharmacovigilance Quality: Key Considerations Room 187 #310: BsUFA III and GDUFA III: Increasing FDA’s Authority to Enhance Competition Room 185 AB #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

#317: Let’s Make a PV Agreement: Four Solutions You Can Use to Enhance Your Entire PVA Process Room 175 #318: Rare Disease Data Sharing: A Value Proposition Room 178 #321: FHIR in Clinical Research Room 180 #320: De-Risking Decentralized: Understanding the Dimensions of Risk and Maximizing Data Quality in Decentralized Trials Room 176 #322: Risky Business – The Sequel: Successfully Manage Program-Level Risk Room 470 A #323: Remote GMP Assessments, Inspections and Audits : Here to Stay? Room 186

11:15am CDT

#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

12:45pm CDT

#336 CH: Reviewing FDA's Draft Guidance on PROs in Oncology Trials: How This Affects Future Measurement Strategy and Study Designs Room 470 B

1:45pm CDT

#340: Monitoring COVID-19 Vaccine Safety Room 178 #342: Democratizing Data for Cancer Research and Real-World Evidence Generation Room 176 #341: New Approaches to Site Selection in Clinical Trials Room 175 #343: Redefining the Value Proposition for Innovation: Connecting Data, Technology, and Quality to Improve Outcomes Room 179 #344: Managing Up and Managing Down: Developing and Advocating for Your Medical Writing Team Room 470 A #345: Statistical Issues in Master Protocols: Beyond Type I Error and Concurrent Controls Room 180 #346: New Global Team: Building and Leading Remote Teams and Non-Fulltime Equivalents (FTEs) Room 470 B

2:00pm CDT

#348: Research and Innovation to Enhance Patient Access to Topical Dermatological Products in the US Room 185 AB #349: The Power and Uncertainty of Data: How it Can be Used to Drive Efficiency While Recognizing its Limitations Room 186 #350: The Transformation of Quality Assurance: The Roadmap Room 185 CD #351: Health Canada Town Hall Room 183 A #352: FDA Rare Disease Town Hall Room 187 #354: How Can Population Decisions Makers and Pharmaceutical Companies Engage Collaborative Research? Room 183 C

3:15pm CDT

#360 CH: Considerations for Establishing Meaningful Change for Digital Endpoints Derived From DHT Drug Development Tools Room 470 A #361 CH: Separating the AI Hype From Reality: A Primer on NLP (Natural Language Processing) Room 470 B

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 #367: Local Conduct for Global Clinical Trials: Focus on Japan, Latin America, and Africa Room 176 #368: Sneak Peak: First Share from Initiatives of a Global Collaboration to Address Barriers to Decentralized Trial Scale and Adoption Room 183 A #370: Where Are we Really on Data Interoperability? Room 185 AB #369: Approaches to Addressing Diversity and Inclusion in Clinical Research Room 185 CD #372: Accelerating Innovation Through Investing Room 186 #373: Effective Oversight Strategies of CROs and Digital Technology Vendors: How to Comply with Health Authority Expectations Room 183 B #375: The Global Impact of ORBIS: Case Studies and Perspectives Room 187 #378: US Health Care System Adoption of a Class of New Technologies for the Treatment of Alzheimer’s Disease: Access Challenges and Opportunities Room 179 #379: Search Within: Maximize your Strengths and Possibilities Room 470 A
 
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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
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Featured Topics
  • AI and Machine Learning
  • COVID-19
  • Data Science
  • Decentralized Trials
  • Digital
  • Diversity Equity and Inclusion
  • Innovative Trial Design
  • Patient Perspective
  • Personalized Health Care
  • Regulator Perspective
  • Remote Work
  • RWD-RWE
  • Special Populations
  • Student Programming