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Type: 09: Regulatory, Session [clear filter]
Monday, June 26
 

10:45am EDT

#110: Disruptive Medicine Innovation: Combination Products Room 153 AB #114: Navigating the Constellation of Efforts to Increase Representation in Clinical Research Room 210 #111: E9(R1) Implementation: Practical Applications of Using Estimands in Protocols, SAPs, Data Standards and Examples of use of Estimands Room 102 #106: New Alternative Methods-Only IND/CTA Application: Distant Dream or Immediate Possibility? Room 253 C #109: Cell and Gene Therapies Pulse Check Room 156

1:30pm EDT

#130: On the Path to Enlightened Conversations: Setting up Structured Content Authoring Room 253 C

4:15pm EDT

#158: Emerging Therapies and Technologies: Leveraging Opportunities for Engaging in Pre-Competitive Research and with Medicine Regulators to Support Innovation Room 153 AB #160: Regulatory Cooperation, Coordination, and Reliance in Times of Crisis: The ICMRA Role Room 104 AB #161: Challenges in Analytical Development of Cell and Gene Therapy Products, Regulatory Perspectives, and Convergence Room 151
 
Tuesday, June 27
 

8:30am EDT

#204: ICH M11 Clinical Electronic Structured Harmonized Protocol (CeSHarP): Enabling Consistency and Information Exchange Room 206 #205: The Case for Generating Synthetic Data as Real-World Data: Regulatory and Planning Perspectives  Room 253 A #136: WHO Town Hall: The New Era of WHO Listed Authorities (WLAs), Reliance in Action, and Country and Regional Focus for Regulatory Systems Strengthening Room 205 A #209: International Regulatory Convergence and Collaboration Room 153 AB #210: Pediatrics and the Paradox of Progress: What’s New, What’s Next, What’s Needed? Room 157 AB

10:30am EDT

#217: Good Recruitment Practice Under Regulation (EU) No 536/2014 Room 254 #224: Time for Alignment? A Policy Landscape Update on the Use and Acceptance of Real-World Data/Real-World Evidence for Regulatory Purposes Room 153 AB #226: Patient Experience Data in the Label: Closing the Loop Room 157 AB #228: A Regulatory Pharmaceutical Quality Knowledge Management System to Improve the Availability of Quality Medicines Room 151

1:15pm EDT

#245: Global Regulatory Perspectives About Real-World Data: DARWIN EU®, FDA, and Other Current Initiatives Room 206 #251: Asia Town Hall Room 153 AB #252: One Dossier and One Timeline for a Post Approval Change: The Story of a Regulatory Reliance Pilot! Room 151

4:00pm EDT

#270: SMART-on-FHIR: Integrating Electronic Health Records as Real-World Data Room 206 #271: IDMP Standards, Structured Submissions, and Data Harmonization Methods: How Will Your Company be Impacted? Room 253 A #276: Globally Accelerating the Drive to eLabeling for All Room 156 #277: Quality and CMC Aspects of Recent US Legislation: Challenges and Opportunities Room 151 #275: PMDA Town Hall Room 153 AB
 
Wednesday, June 28
 

8:30am EDT

#306: Writing Summary Documents for Rare Disease Submissions: Unique Challenges Room 253 C

10:30am EDT

#317: Leveraging Data Scientists and Data Managers in Clinical Data Management Room 206 #321: What Can ICH Bring to the Future of Model-Informed Drug Development (MIDD)? Room 204 #322: PI 1572 Responsibility and Oversight in Decentralized Clinical Trials Room 253 B #323: 25-Years After FDAMA: How is FDA Applying the Confirmatory Evidence Standard for Substantial Evidence of Effectiveness? Room 153 AB #326: Reliance in Action: How to Ensure Product Sameness When Using Global Supply Chains Room 151 #327: Patient-Focused Drug Development in Rare Disease Endpoint Selections Room 102

11:45am EDT

#332: Roundtable Discussion: Strategies for Benefit-Risk Analysis in Regulatory Submissions Grand Ballroom Zone 3

1:15pm EDT

#340: Regulatory Insights into Decentralized Clinical Trials Room 254 #348: The Future of Biosimilar and Interchangeable Biologics: Global Development, Harmonization, and the Inflation Reduction Act Room 156 #342: Real-World Data Standards and Protocol Designs for Information Exchange and Data Flow  Room 253 A #349: Evolving Global Landscape for Addressing Drug Shortages: Innovative Technology and Regulatory Strategies Room 151

4:00pm EDT

#363: Modernizing the Clinical Trials Environment in Europe: ACT EU and the New EU Clinical Trial Regulation Room 253 A #370: Regulatory Reliance: Addressing Gaps to Harmonize and Enhance Uptake Globally Room 156 #371: ICH Work to Harmonize Requirements for Safe and Effective Medicines: What’s in It for Patients? Room 157 AB
 
Thursday, June 29
 

8:30am EDT

#404: Implementation of the New EU Clinical Trials Regulation Room 253 C #408: FDA Sponsor Interaction: Best Practices and New PDUFA Formal Meetings Room 153 AB
 
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Ballroom Lobby 3
Content Hub NE Lobby
DIA Booth #539 EH
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Virtual
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient Engagement
  • 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
  • Artificial Intelligence (AI)
  • Benefit - Risk
  • Cell and Gene Therapy
  • Decentralized Clinical Trials (DCTs)
  • Digital Technology
  • Diversity Equity and Inclusion (DEI)
  • Dose Optimization
  • Endpoints
  • Ethics
  • Patient Focused
  • Rare Disease
  • Real-World Data (RWD) - Real-World Evidence (RWE)
  • Regulator Thinking
  • Regulatory Collaboration
  • Student Programming