Regulatory Agency Meetings – Your guide to EOP2 meeting preparation
The end-of-phase 2 (EOP2) meeting with FDA is a critical milestone in your development program and likely the most important interaction you will have with the Agency. Getting the most from this meeting can help successfully launch your Phase 3 program and help you begin preparing for your marketing application (NDA/BLA) submission. If you are nearing completion of your phase 2 study or you are planning phase 3 programs, this webinar is built just for you.
This webinar covers:
- Goals for your EOP2 meeting
- What does it mean to be phase 3 ready?
- Developing the right questions to obtain clarity from FDA
- Timing considerations
- Common themes in FDA feedback
Rho’s dedicated regulatory strategy and submissions team is led by professionals with over 20 years of experience in clinical research, product development, data standards, quality assurance and regulatory affairs.
David Shoemaker, Ph.D.
Senior Vice President, Research & Development
Dr. David Shoemaker has been a trusted regulatory advisor to international clientele for close to 30 years, providing…
Kevin Barber, Ph.D.
Vice President, Regulatory Strategy & Submissions
Combining extensive strategic leadership, scientific knowledge, and regulatory expertise, Dr. Kevin Barber supports Rho’s clientele in the development…