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
Monday, June 21-Friday, June 25 | Short Courses
- #013A: “Has it Happened Already?” Questions of Precedent from Which Regulatory Intelligence Can Save You
- #025F: Optimizing Your Interaction with EU Regulatory Authorities: How to Prepare and Perform
- #041A: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development
- #042P: Compliance by Design: Blockchain in Clinical Research and Drug Development
- #051A: Regulatory Submissions and Interactions with NMPA: What You Need to Know
Monday, June 28
- Electronic Labeling: Where Are We Now and What Are the Next Steps in the World?
- Using Cloud-Based Platforms to Transform Global Regulatory Data Exchange
- FDA Perspectives on Modernization of Clinical Trials: Clinical Practice Data, Decentralized Trials, Digital Health Technologies
- Global Trends in Regulatory Reliance: Will the COVID-19 Experience Accelerate Implementation?
- Health Canada Town Hall
- Parallel Scientific Advice: Increasing International Dialogue Early in the Product Lifecycle
- If You Have Questions, Contact the Regulatory Project Manager: Best Practices when Interacting with US FDA Regulatory Project Managers
- NMPA Town Hall
- Continuity of Randomized Controlled Trials During the Trying Times of COVID-19 and what We’ve Learned
- Next Generation of Combination Products: Insights from the FDA Office of Combination Products and Industry Expert Application
Tuesday, June 29
- FDA Oncology Center of Excellence Pilot Programs: Past, Present, and Future
- Advancing Medicines’ Regulation in Europe: Key Strategies to 2025
- Office of Generic Drugs and Office of Pharmaceutical Quality Generics Town Hall
- Gene Therapy: Getting Back on Track After COVID-19
- Global Regulatory Harmonization for Increased Patient Access to Medicines Through the International Council for Harmonisation (ICH)
- Update on FDA's Vision on Real-World Evidence: Current FDA Projects
- How to Engage with EMA Early in Development? Navigating the European Ecosystem to Bring Innovation to Patients
- Frameworks for Digital Endpoints via the IND Pathway
- Pandemic Preparedness: Accelerating Treatments to Overcome Antimicrobial Resistance
Wednesday, June 30
- Comparing Accelerated Approval Pathways Among EMA, FDA, and PMDA
- Model Informed Drug Development (MIDD) Pilot Program: Experience and Impact Over First Three Years
- Regulatory Cooperation and COVID-19
- The FDA's Clinical Trial Diversity Initiative in the Setting of the Ongoing COVID-19 Pandemic
- PMDA Town Hall
- How Has FDARA Section 504 (RACE Act) Changed the Pediatric Oncology Landscape?
- Scientific Advances in Biosimilar Development
- COVID-19 Vaccines: Regulatory Strategies for Public Health Emergencies
Thursday, July 1
- Asian Town Hall
- The International Coalition of Medicines Regulatory Authorities (ICMRA) Achievements
- US Marketing Application Integrated Review: A View into FDA Internal Operations
- Emergency Use Pathways: What Leanings from COVID-19 Can Be Generalized to Address Unmet Medical Needs?
- Real-World Evidence: A Global Regulatory Perspective and Discussion
- Managing in Complexity: Emergency Use Authorizations Process and COVID-19 Lessons Learned
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.