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 regulatory and scientific expertise for integrated product development programs across a wide range of therapeutic areas. Dr. Shoemaker has extensive experience in all stages of investigational product development, has moderated dozens of regulatory authority meetings, and has managed and contributed to over one hundred INDs, over a dozen IMPDs, and dozens of successful marketing applications across the majority of reviewing divisions at FDA and several international regulatory authorities. At Rho, Dr. Shoemaker serves as an expert scientific and regulatory reviewer for documents…
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 and execution of integrated regulatory strategies and clinical development plans for drugs, biologics, and medical devices. With close to 25 years of experience in regulatory affairs and product development, Dr. Barber is a regulatory expert across all phases from preclinical through product launch and post-approval life cycle management. His significant experience moderating regulatory authority meetings and preparing and filing regulatory submissions includes more than 45 US INDs and more than 40 global marketing applications. Throughout his career, Dr. Barber has participated in…