The Roundtable Dinner will feature a networking reception with complimentary bar, followed by a buffet dinner with seating at multiple tables, each featuring a speaker who will lead the dinner discussion on a different topic. Topics include:
- GDPR and the New World of Data Privacy
- How to Kill Your Biotech Startup
- Regulatory Intelligence - Building Strategies for Drug Development in the Changing Regulatory Landscape
- CHMP Oral Explanations and FDA Advisory Committee Meetings - Understanding Similarities and Differences to Optimize Your Meetings
- Due Diligence in GxP Supplier Selection
- Orphan Drug Development: U.S. Regulatory Landscape
- FDA Policy: Are the Incentives Right for Orphan Drugs?
- Artificial Intelligence in Medical Devices
- How is your company preparing for the MDR/IVR?
- Right-to-Try or Right-to-Ask? Understanding Right-to-Try and FDA's Expanded Access
- Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics
- How to Write a Good Audit Report
- Gene Therapies and Advanced Tissue Therapies: FDA and EMA Pathways
- Best Practices for Preparing for FDA Meetings
Register early to get the table of your choice - many tables sell out well before the event date! Learn more.
Networking Reception 5:30 - 6:30 p.m.
Buffet Dinner and Roundtable Discussions 6:30 - 8:00 p.m.