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Is Gaining Drug Approval More Difficult in Europe Than the US, or Vice Versa?
Program Code:
3104
Date:
Tuesday, May 19, 2009
Time:
4:00 PM to 5:30 PM
EST
SPEAKER
(S):
Alberto Grignolo, PhD, PAREXEL International Corporation
Ken Kaitin, PhD, PhD, Tufts Center for the Study of Drug Development/Tufts University
Lesley Russell, MRCP, Cephalon, Inc
Joseph Scheeren, PharmD, Bayer Corporation
Jack Talley, EpiCept Corporation
Description
In recent years, receiving same drug approvals from both the FDA and EMEA have been far from guaranteed. For example, Vectibix, Mylotarg, Revlimid and Rozerem were approved by FDA, but not by EMEA. On the other hand, Accomplia, Cordaptive, sugammadex and ceftobiprole were given positive opinions by EMEA, but were not approved by FDA. Is this an anomaly or a new reality? This session invites the panel to discuss the challenges and lessons in seeking drug approvals in the EU and US.
• Provide an overview of the key trends in drug approvals at the FDA and EMEA
• Learn the approaches for drug approval in Europe and
decision-making process
• Identify nuances and potential pitfalls in working with the EMEA versus FDA