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Type: 09: Regulatory [clear filter]
Monday, June 13
 

10:00am CDT

11A: “Has it Happened Already?” Questions of Precedent from Which Regulatory Intelligence Can Save You Virtual
 
Tuesday, June 14
 

2:00pm CDT

23P: Real-World Evidence: The Evolving Landscape of Regulators, Data, and Integrated Use Virtual
 
Wednesday, June 15
 

10:00am CDT

31A: Global AdPromo: Considerations for Compliance and Success Virtual
 
Thursday, June 16
 

8:00am CDT

41A: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development Virtual
 
Monday, June 20
 

1:15pm CDT

#108: Support of IND Safety Reporting by the Aggregate Safety Assessment Plan (ASAP) Room 175

1:30pm CDT

#118: Real-World Evidence Frameworks Across the World: Three International Perspectives Room 184 #119: Is it Time to Change the Accelerated Approval Pathway? Room 187

4:00pm CDT

#131: Innovations for Implementing REMS Room 185 CD #132: ICH E2D Update: Innovations in Collecting Safety Data from Disparate Sources Room 175 #134: FDA Update on the Upcoming PDUFA VII Data and Technology Commitment Room 178 #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 #212: Where Are We with Antimicrobial Resistance (AMR) in the Regulatory Space? Room 185 AB #213: Reflections on PDUFA: A Look Back at PDUFA VI and A Preview of PDUFA VII Room 187 #214: New Policy Developments in Combination Products Room 185 CD

11:00am CDT

#221: Complying with the EU-CTR Disclosure Standards in the Era of GDPR Room 470 B #224: ICMRA Update: Convergence and Collaboration on COVID-19 - Learning from the Present for the Future Room 179 #223: Meeting Regulatory Expectations: What Needs to be Considered When Using Digital Technologies to Generate Clinical Evidence? Room 175

11:15am CDT

#230: Asia Town Hall Room 186 #229: Accelerating Cell and Gene Therapy Development Through International Regulator Collaboration Room 185 AB

12:30pm CDT

#236 RT: Round Table Discussion: FDA Update on the Upcoming PDUFA VII Data and Technology Commitment Room 375 A Zone 1

2:00pm CDT

#249: Regulatory-Grade Real-World Evidence: Distilling to Practice Room 183 A #252: International Collaborations: What’s New in Oncology? Room 184 #254: Overcoming Challenges in Pediatric Product Development Room 187 #253: Efforts to Improve Diversity of Clinical Trial Participants Room 185 AB

4:15pm CDT

#266: FDA's Updates on Ensuring Post Market Safety and Surveillance for Generic Drugs Room 178 #271: Building the First Cloud-Based Submission Review Collaboration Platform Room 184 #274: Regulatory Convergence Successes and Opportunities Room 179 #275.1: PMDA Town Hall Room 183 B #275: How to Interact with Regulators to Qualify a Digital Mobility Outcome? Room 185 CD
 
Wednesday, June 22
 

9:15am CDT

#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

11:15am CDT

#328: Approaches to Health Authority Collaboration: Are They Fit-for-Purpose and How Should They Evolve Post-Pandemic? Room 183 B #330: Leveraging Real-World Evidence to Address Diversity Gaps in Randomized Clinical Trials: Regulatory, Clinical, and Other Considerations Room 184

2:00pm CDT

#351: Health Canada Town Hall Room 183 A #352: FDA Rare Disease Town Hall Room 187

3:00pm CDT

#356 RT: Round Table Discussion: Planning for the Worst: Approaches for Drug Shortage Avoidance Room 375 A Zone 2

4:15pm CDT

#373: Effective Oversight Strategies of CROs and Digital Technology Vendors: How to Comply with Health Authority Expectations Room 183 B #374: Around the World: Regulator Perspectives on Decentralized Clinical Trials Room 184 #375: The Global Impact of ORBIS: Case Studies and Perspectives Room 187
 
Thursday, June 23
 

10:00am CDT

#404: Combination Product Safety: A Journey of Organizational Transformation Room 175 #408: Writing at Lightspeed: Optimizing Submission Dossiers in Today’s Environment Through Better Processes, Planning, and Technology Room 180 #410: Addressing Gaps in the Use of Real-World Evidence for Regulatory Decision-Making Room 187 #411: FDA Oncology Center of Excellence’s Real-Time Oncology Review Program: 2022 Update Room 183 A
 
Monday, June 26
 

10:45am CDT

Cell and Gene Therapies Pulse Check TBD Diversity and Inclusion Implications for Global Regulatory TBD

1:30pm CDT

Combating Misinformation with Authoratative Medical Product Information TBD Novel Biomarkers and Surrogate Endpoints in a Rare Disease TBD WHO Town Hall: The New Era of WHO Listed Authorities (WLAs), Reliance in Action, and Country and Regional Focus for Regulatory Systems Strengthening TBD

4:15pm CDT

Emerging Therapies and Technologies and Leveraging Opportunities for Engaging with Medicine Regulators to Support Innovation TBD Regulatory Cooperation, Coordination, and Reliance in Times of Crisis: The ICMRA Role TBD The Promise of Vaccine Platforms to Advance Regulatory Science: Where are we Now, Where are we Going, and How do we get There? TBD
 
Tuesday, June 27
 

8:30am CDT

International Regulatory Convergence and Collaboration TBD Pediatrics and the Paradox of Progress: What’s New, What’s Next, What’s Needed? TBD

10:30am CDT

ANVISA Townhall TBD International Harmonization of Real-World Data/Real-World Evidence Use and Acceptance by Health Authorities: Time to Make it Right! TBD Patient Experience Data in the Label: Closing the Loop TBD Post-Pandemic Regulatory Innovation for Clinical Trials and Opportunities for Global Alignment TBD

1:15pm CDT

Asia Town Hall TBD Implementing Digital Health Technologies in Clinical Trials: How to Apply New Resources to Address Key Questions TBD

4:00pm CDT

Globally Accelerating the Drive to eLabeling for All TBD PMDA Town Hall TBD
 
Wednesday, June 28
 

8:30am CDT

Strategies for Benefit-Risk Analysis in Regulatory Submissions TBD

10:30am CDT

25-Years After FDAMA: How is FDA Applying the Confirmatory Evidence Standard for Substantial Evidence of Effectiveness? TBD Dose Optimization in Oncology: How Do we Tackle the Tricky Topic of Combinations? TBD Health Canada Town Hall TBD

1:15pm CDT

FDA Rare Disease Town Hall TBD The Future of Biosimilar and Interchangeable Biologics: Global Development, Harmonization, and the Inflation Reduction Act TBD

4:00pm CDT

Modernizing the Clinical Trials Environment in Europe: ACT EU and the New EU Clinical Trial Regulation TBD Mobilizing Cooperation with the African Medicines Agency TBD Regulatory Reliance: Addressing Gaps to Harmonize and Enhance Uptake Globally TBD
 
Thursday, June 29
 

8:30am CDT

FDA Sponsor Interaction: Best Practices and New PDUFA Formal Meetings TBD International Medical Device Regulators Forum (IMDRF) and Technological Innovation: How International Medical Device Harmonization is Impacting Drug Strategy TBD
 
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Monday, June 13
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Monday, June 20
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Wednesday, June 22
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Monday, June 12
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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