How to Prepare for Meetings, Both Internal and with the FDA

Track:
Pharmaceutical Quality

Day & Time:
June 26, 8:00AM - 9:30AM

Session Number:
315

Room Number:
156C

Level:
Basic

Type:
Workshop

Title:
How to Prepare for Meetings, Both Internal and with the FDA

Chair(s):
Antoinette Paone, MBA,MSc
Senior Director, Global CMC Regulatory Affairs Strategy
Vertex Pharmaceuticals, United States

Description:
Meetings with the FDA are an important and essential tool for industry sponsors to identify and discuss critical review issues. This workshop will present a thoughtful and organized approach to meeting preparation that fosters Industry and Agency collaboration and assists in achieving meeting goals.

**Due to workshop format, seating will be limited and will be available on a first come, first served basis.

The Boston Convention and Exhibition Center (BCEC) has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive at workshops early in order to ensure seating. Please note, as a workshop with interactivity, this event will not be recorded.

Learning Objective(s):
Identify key steps in requesting, planning for and conducting a meeting with the FDA; Discuss best practices for organizing and running a meeting with the FDA.

Presentation(s) & Speaker(s):
Facilitator
Bink Garrison
President
Bink, Inc., United States

Facilitator
Stephanie Krogmeier, PhD,RPh
Director, Global CMC Regulatory Affairs Strategy
Vertex Pharmaceuticals, United States