DIA 2013 49th Annual Meeting
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Global Development of Novel Combination Products: Regulatory and Clinical Case Studies from Biotech and Pharma Sponsors
Track
:
Track 09: Medical Devices, In Vitro Diagnostics, and Combination Products
Program Code:
375
Date:
Wednesday, June 26, 2013
Time:
4:00 PM to 5:30 PM
EST
Location:
253C
CHAIR
:
Kevin B. Johnson, PhD,MBA (SCHNON), Global Head, Regulatory Affairs, Novella Clinical, United States
SPEAKER
(S):
Cynthia Joan Nolte, PhD (SPKNON), Director, Medical Device Regulatory Services, Aptiv Solutions, United States Suzanne M. O'Shea, JD (SPKNON), Counsel, Faegre Baker Daniels, United States
James S. Cohen, Esq (SPKNON), Partner, Head, FDA Practice, McDermott Will and Emery, United States
Description
This forum will present targeted, real-world case studies from biotechnology and pharmaceutical sponsors as well as a CRO on the development of novel combination products with a particular focus on global regulatory strategy and implementation.
This session is a part of:
This session is a part of: