CHAIR
:
Roy Baranello, Jr., Assistant Vice President, Regulatory Policy and operations, Wyeth
SPEAKER
(S):
Matthew Eckel, J.D., Director, Europe, Harmonization, Trade Staff Office of International Programs, United States Food and Drug Administration
John Purves, , Head of Sector, EMEA European Medicines Agency
Description
In this session, senior staff from the Food and Drug Administration and the European Medicines Agency (EMEA) will present key regional regulatory initiatives, as well as FDA/EMEA collaborations. Topics may include, for example, joint briefings on voluntary genomic data submissions, mechanisms for parallel scientific advice and accelerated approvals, and international harmonization of regulatory requirements.
Objectives:
Learn about key FDA and EMEA organizational and policy initiatives.
Learn about FDA/EMEA collaborations.
Stimulate interactive discussion among FDA, EMEA and attendees with respect to the initiatives and issues presented.