Track 9: Regulatory
This track is composed of 23 sessions addressing global laws, regulations, guidelines, and guidances that govern prescription biopharmaceutical and device product development, approval, and maintenance. Representatives from FDA, EMA, PMDA, MHRA, BfArM, and ICMRA authorities, and other regulatory experts will provide global updates, insights, and discussion on current issues, opportunities, and challenges through interactive forums. Themes include, Global Regulatory Changes and Impact on Global Development Strategies, Global Harmonization/Convergence and Impact on Drug Development, Advances and Innovations to Improve the Practice of Regulatory Affairs, and Regulatory Hot Topics.
Sessions in Regulatory
Sunday, June 24 | Short Courses
- Preparing for a US FDA Advisory Committee Meeting
- Precedent: A Driver of Regulatory Strategy
- Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development
- FDA Advisory Committee Purpose and Non-inferiority Case Study: Rivaroxaban
Monday, June 25
Analyzing Innovation’s Progress in the Gottlieb Era
- How Can We Optimally Incorporate Real World Evidence into Regulatory Decision-Making?
- FDA Expectations for Demonstration of Interchangeability
- Using Real World Evidence for Regulatory Support: Time to Embrace the Future
- ‘Target’ing Pediatric Oncology Development: New Global Pediatric Considerations Under FDARA 2017
- TFDA Town Hall
- On the Soap Box: Right to Try
International Regulatory Convergence
Tuesday, June 26
- Priority Review Vouchers: Here to Stay and Worth the Effort?
- Update on Collaboration and Trends in Global Companion Diagnostics
- Artificial Intelligence: The Future of Regulatory Affairs
- Global Regulatory Strategies for Biosimilars
- Generic Drug Town Hall
- Expanded Access: Where Are We Now?
- The European Medical Devices Regulation and MDUFA IV: One Year on – Is it Any Clearer?
- Navigating the Regulatory Landscape of Drug-Device Combination Products
- Global Development Using Expedited Pathways in Established and Emerging Markets
- Electronic Submissions Demystified
- Is it Time to Change the Content and Format of Labeling?
Wednesday, June 27
- Harmonizing Regulatory Science Through the International Council for Harmonisation (ICH)
- What Can We Say About Combination Products? Labeling, Advertising, and Promotion of Combination Products
- Global Rare Disease Town Hall
- Harmonization Beyond ICH
- Sex Considerations in the FDA Drug Review Pipeline: The Where, When, and How
- New FDA Draft Guidance on Part 11 in Clinical Investigations
- What's New in Health Canada: Updates and New Endeavors
- Clinical Outcome Assessments (COA) Endpoints for Use in Rare and Ultra-Rare Disease Clinical Trials
- PMDA Town Hall
- AdPromo: Assessing Risk in the Current Regulatory Environment
- PDUFA VI: Improving Transparency and Accountability of Electronic Submission and Data Standards Activities
- Update on BREXIT
Thursday, June 28
EMA/FDA Question Time
- Regulatory and Industry Perspectives on the Common Protocol Template
- Metrics and Meaning: Evolving Metrics in Generic Drug Application Review and Communications to Improve ANDA Submission Planning and Approvability
FDA 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.