DIA 2013 49th Annual Meeting
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Co-development of Targeted Therapies and Companion Diagnostics: Identifying Regulatory Strategies to Overcome Challenges
Track
:
Track 09: Medical Devices, In Vitro Diagnostics, and Combination Products
Program Code:
255
Date:
Tuesday, June 25, 2013
Time:
1:45 PM to 3:15 PM
EST
Location:
253C
CHAIR
:
Janet Jenkins-Showalter, (SCHNON), Senior Regulatory Group Director, Regulatory Policy and Intelligence, Genentech, A Member of the Roche Group, United States
SPEAKER
(S):
Erling Thor Donnelly, PhD,RAC (SPKNON), Manager, Worldwide Regulatory Strategy, Pfizer Inc, United States Shayesteh Fuerst-Ladani, MBA,MS (SPKNON), Director, SFL Regulatory Affairs & Scientific Communication, Switzerland
Description
FDA released a draft guidance in July 2011 that outlined the basics on developing targeted therapies and companion diagnostics, but it left many questions unanswered. This session will discuss potential approaches to address these remaining questions.
This session is a part of:
This session is a part of: