DIA 2013 49th Annual Meeting
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How to Prepare for Meetings, Both Internal and with the FDA
Track : Track 12: Pharmaceutical Quality
Program Code: 315
Date: Wednesday, June 26, 2013
Time: 8:00 AM to 9:30 AM  EST
Location: 156C
CHAIR :
 Antoinette Paone, MBA,MSc (SPKNON), Senior Director, Global CMC Regulatory Affairs Strategy, Vertex Pharmaceuticals, United States
SPEAKER (S):
 Bink Garrison, (SPKNON), President, Bink, Inc., United States
 Stephanie Krogmeier, PhD,RPh (SPKNON), 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.