An Ocean Apart? Integrating Distinct Health Authority Philosophies on Personalized Medicines and Companion Assays
Track
:
Track 08: Regulatory Affairs and Submissions
Program Code:
250
Date:
Tuesday, June 26, 2012
Time:
1:30 PM to 3:00 PM
EST
CHAIR
:
Jeffrey Stuart, Novartis Pharmaceuticals Corporation, United States
Stuart is a Regulatory Affairs Certified professional whose current interests include personalized medicine and drug-diagnostic co-development. He co-authored the original RAPS Online Training Course, “Regulation of IVDs” and has authored numerous scientific publications.
Dr. Mansfield is the Director of the Personalized Medicine Staff in the Office of in vitro Diagnostic Devices in the Center for Devices, FDA. She is working to develop critical structures and policies to aid in advancing personalized medicine.
Linda Burdette, Hoffman-La Roche Inc., United States
Deputy Head of Sector for Safety and Efficacy of Medicines at the Human Unit of the European Agency for Medicines. Former Scientific Secretary of the biotechnology Working Party. Currently in charge of the EMEA activities in the field of innovation at EU and Int. level.
Description
Recently FDA and EMA released guidance to assist with co-development, but creation of a global registration strategy remains challenging. This session will bridge diverse regulatory perspectives to accelerate global co-development efforts.
Learning Objectives: Summarize synergies and divergences between various health authority policies on co-development and co-registration Apply information to form pragmatic global development and registration strategies for co-developed medical products.