How to Prepare for an FDA Meeting: Making the Most of Pre-IND/IDE, pre-NDA and Other Critical Meetings

Despite a few guidance documents to help sponsors prepare for meetings with the FDA, it is a challenge to understand the most efficient and productive ways to strategize, prepare, conduct, and follow-up for these meetings. There are many misconceptions about the expectations from these meetings both for the sponsor and the FDA, and hence many sponsors fail to get the most benefit from them. Over the years, the FDA has also revised processes and practices for meeting with sponsors.

This two day seminar will provide valuable tips about the logistics, planning, conduct and best practices for all kinds of meetings with the FDA. Throughout the workshop, the author will discuss case studies and examples to highlight the common errors and potential solutions. This workshop contains a collection of practical tips from the instructor’s extensive FDA meeting experience. This one-of-a-kind workshop will provide step-by-step instructions and practical tips to the most productive meeting with FDA for all FDA-regulated organizations.

Learning Objective:

• Understanding different stages of FDA meetings: pre-IND, Pre-IDE, Pre-NDA, pre-PMA, End-of-Phase 2
• Creating rationale for FDA meetings
• Requesting process for FDA meetings
• Creating a meeting information package and its regulatory requirements
• Logistics of an FDA Meeting
• Learn FDA meeting follow ups