You’ve sent in a request to the FDA for a meeting, just to find you only have 60 minutes to address your long list of questions. Budgets and timelines suggest your product’s development is both lengthy and costly. How do you know you’re on the right track? With few opportunities to obtain the Agency’s buy-in, you need to get the most you can out of each meeting with the Agency. Whether you are attending a Pre-IND Meeting, an End of Phase 1 Meeting, an End of Phase 2 Meeting or a Pre-BLA/Pre-NDA Meeting, this session will cover key strategies to help you streamline the development of your background materials and conduct an effective meeting with the Agency. It’s your meeting, make the most of it!
This detailed, 90-minute session will help you navigate complex relationship strategies and brainstorm ideas to set you up for success. Topics include:
- How to effectively write and present you background materials including questions to the Agency
- How to effectively respond to Agency comments
After attending this interactive live session you will be able to:
- Apply regulatory strategy to streamline your questions and background material
- Prioritize items to discuss during the 60 minute
- Conduct a successful meeting with the FDA