How to Best Navigate an EOP2 Meeting
The time will come when you need to review and obtain agreement from the Food and Drug Administration (FDA) on your study designs for Phase 3, and an EOP2 Meeting is necessary. During this meeting, you need to effectively present your Phase 3 and submission strategy and ensure that you are aligned with the FDA prior to the start of Phase 3.
Preparation for EOP2 Meeting
To move you to the next clinical trial phase, ProPharma Group will diligently work with you to prepare for the EOP2 Meeting. With your input, our experts will:
- Develop the EOP2 briefing package to be sent to FDA in advance of the meeting
- Request the EOP2 Meeting
- Determine meeting objectives and agenda and script the participants
- Conduct a meeting rehearsal at our offices in Washington, DC
- Attend the meeting with you and summarize results in formal notes
- Conduct a debriefing session to discuss the accomplishment of meeting objectives and finalize meeting minutes to be sent to the FDA
ProPharma Group: Continuing to Phase 3
Our team of experts will work closely with you to ensure your EOP2 Meeting with the FDA delivers the feedback necessary so you may continue with your Phase 3 clinical trials.