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Today is Sep 5, 2010
December 15, 2004
Time: 12:00 PM to 1:30 PM
Topic: Local FDA's Historical Perspective and Current Understanding of Clinical Sites and Sponsor FDA Audits
Speaker: Darlene Almogela, San Francisco District Supervisor, FDA
Location: Alza Corporation
1900 Charleston Road
Main Lobby, Building M10
Mountain View, California, California
Get Map and Directions
Lunch may be purchased at the Alza cafeteria before the meeting.
Speaker Biography
Darlene Almogela is currently the Supervisor for the Drug/Bioresearch monitoring (BIMO) group of San Francisco District Office of the US Food and Drug Administration. She is the District's contact with CDER/CDHR/CVER/CVM for all BIMO issues. she is the District's contact for all CDER related issues. She conducts the QC review of the Drug and BIMO work products produced by the District Ofice Drug/BIMO Investigators and ensures that any proposed regulatory actions are facilitated through the local Compliance Branch and to the appropriate Centers.

Ms. Almogela started her career in 1992 in the New England Regional Office. She transferred to the San Francisco District Office in 1995. From 1995 on, her work assignments have been primarily within the pharmaceuticals and BIMO areas.
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