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Program Code:
3901
Date:
Wednesday, May 20, 2009
Time:
10:00 AM to 11:30 AM
EST
SPEAKER
(S):
Thomas Lonngren, European Medicines Agency (EMEA)
Murray Lumpkin, MD, U.S. Food and Drug Administration
Patricia DeSantis, Johnson & Johnson
Description
Medicines Agency (EMEA) will present key regional regulatory initiatives, as well as FDA-EMEA collaborations. Topics may include, for example, mechanisms for parallel scientific advice and accelerated approvals and international harmonization of regulatory requirements.
• Outline key FDA and EMEA organizational and policy initiatives
• Discuss FDA-EMEA collaborations
• Stimulate interactive discussion with respect to the initiatives and issues presented