PDA Drug Delivery Combination Products Workshop 2015

This workshop will provide real-life experiences from leading pharmaceutical and biotech companies and updates and recommendations from the U.S. FDA, arming you with implementable solutions to today’s challenges in the development, approval and manufacture of combination products.

Agenda
Wednesday, May 20, 2015
7:00 a.m. - 5:15 p.m. Registration Open
7:00 a.m. - 8:00 a.m. Continental Breakfast
8:00 a.m. - 8:05 a.m. Welcome and Opening Remarks Lee Leichter
8:05 am. - 10:00 a.m. P1 - Opening Plenary Session – GMPs: Premarket System Requirements Moderator: Lee Leichter
8:05 a.m. - 8:35 a.m. FDA Perspectives Regarding GMPs John Weiner
8:35 a.m. - 9:05 a.m. Industry Perspectives Regarding GMPs Kristi Kistner
and much more...