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.

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

Who will Benefit:

Regulatory affairs professionals

Senior management executives (CEO, COO, CFO, etc.)

Project managers

Clinical trial specialists

Regulatory compliance associates and managers

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/how-to-prepare-for-an-fda-meeting-of-pre-ind-ide-pre-nda-seminar-training-80111SEM-prdsm?channel=sciencedz