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DIA 2018 Global Annual Meeting
- — FDA Expectations for Demonstration of Interchangeability
- — How Can We Optimally Incorporate Real World Evidence into Regulatory Decision Making?
- — ‘Target’ing Pediatric Oncology Development: New Global Pediatric Considerations Under FDARA 2017
- — TFDA Chinese Taipei Town Hall
- — Using Real World Evidence for Regulatory Support: Time to Embrace the Future
- — Artificial Intelligence: The Future of Regulatory Affairs
- — Global Regulatory Strategies for Biosimilars
- — Update on Collaboration and Trends in Global Companion Diagnostics
- — Expanded Access: Where Are We Now?
- — Generic Drug Town Hall
- — The European Medical Devices Regulation and MDUFA IV:One Year On - Is It Any Clearer?
- — Global Development Using Expedited Pathways in Established and Emerging Markets
- — Navigating the Regulatory Landscape of Drug-Device Combination Products
- — CFDA Town Hall
- — Electronic Submissions Demystified
- — Is It Time to Change the Content and Format of Labeling?
- — Global Rare Disease Town Hall
- — Harmonizing Regulatory Science Through the International Council for Harmonisation (ICH)
- — What Can We Say About Combination Products? Labeling, Advertising and Promotion of Combination Products
- — Harmonization Beyond ICH
- — New FDA Draft Guidance on Part 11 in Clinical Investigations
- — Sex Considerations in the FDA Drug Review Pipeline: The Where, When, and How
- — AdPromo:Assessing Risk in the Current Regulatory Environment
- — Clinical Outcomes Assessments (COA) Endpoints for Use in Rare and Ultra-Rare Disease Clinical Trials
- — PMDA Town Hall
- — What's New in Health Canada: Updates and New Endeavors
- — PDUFA VI: Improving Transparency and Accountability of Electronic Submission and Data Standards Activities
- — Update on BREXIT