Track 9: Regulatory
This track is composed of sessions addressing global laws, regulations, guidelines, and guidances that govern prescription biopharmaceutical and device product development, approval, and maintenance. Representatives from FDA, Health Canada. NMPA, PMDA, EMA, MHRA, European Health Authorities and ICMRA authorities, and other regulatory experts will provide global updates, insights, and discussion on current issues through interactive forums. Themes commonly revolve around Global Regulatory Changes and Impact on Global Development Strategies, Global Harmonization/Convergence and Impact on Drug Development and Advances and Innovations to Improve the Practice of Regulatory Affairs, and Regulatory Hot Topics are always prominently featured.
Sessions in Regulatory
Sunday, June 14 | Short Courses
- #25: Regulatory Requirements for IND/NDA Procedures in China
- #26: "Has it Happened Already?" Questions of Precedent from Which Regulatory Intelligence Can Save You
- #34: Preparing for a US FDA Advisory Committee Meeting
- #35: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development
Monday, June 15
- International Convergence on Regulatory Review and HTA: Getting the “Universal Evidence” We Need for Decisions on Innovation
- Is Your App a Drug, a Device, or Something Else Entirely?
- FDA’s Considerations on Benefit-Risk Assessment for Human Drug Review
Tuesday, June 16
- Using Artificial Intelligence to Inform Regulatory and Development Strategies
- Accelerated Approval and Emerging Surrogate Endpoints
- Utilizing Cloud-Based Platforms in Regulatory Contexts
Wednesday, June 17
- Strategic Directions from Global Medicines Regulators: the ICMRA Statement on Combating Antimicrobial Resistance
- Pediatric Development During COVID-19: Can Increasing Collaboration Lead to Fewer Unnecessary Trials?
- Best Practices for Virtual Meetings with FDA!
- Advanced Therapy Medicinal Products: Facilitating Individualized Gene Therapies and Cell-Based Therapeutics
Thursday, June 18
- Catalyzing the Integration of Digital Technologies in Healthcare Solutions
- FDA-PAHO: Landscape Report of Regulatory Situation in the Americas
- New Drugs Regulatory Program Modernization
- ICH 30th Anniversary: Achievements and Future Prospects
- Translating Frequently Collected Patient Experience Data into Meaningful Trial Endpoints
- PMDA Town Hall: The Path of a New Chief Executive Since His Appointment
- Advancing Clinical Trial Innovation Through Model-Informed Drug Development
- Regulatory Barriers to Entry for Biosimilars
- What Makes Real World Data Trustworthy: A Focus on Design and Data
- Strengthening Food and Drug Regulatory Systems Abroad: Recommendations from the FDA-Commissioned NASEM Report
- NMPA Town Hall
Who is This Track Designed For?
Professionals involved in: Regulatory affairs and strategy, regulatory operations, regulatory information management, regulatory agencies, government affairs, legal affairs and compliance, policy and intelligence, clinical research and operations, PV, HTA, project management, and service providers developing tools and resources for use by sponsors and CROs.