The Israel Analytical Chemistry Society
is proud to present
one of the more influential FDA experts:

Dr. Moheb M. Nasr

Director of the Office of New Drug Quality Assessment,
CDER (Center for Drug Evaluation and Research), FDA, USA

Dr. Nasr will answer questions in a special session:
Meet the Regulator
as part of ISRANALYTICA 2008
on Wednesday 23.1.2008 between 10:30-12:15

You are invited to present Dr. Nasr questions related to CMC, file applications, FDA policies on pharmaceutical topics and related regulatory issues to and to receive, on the spot, insightful answers.

Participants wishing to present a question are invited to send their question/s to Dr. Bar, the session moderator at: rbar@netvision.net.il no later than January 10th, 2008 

         Introduction lectures:

	10:30 – 10:50 QUALITY TESTING OF DRUGS BY THE REGULATOR VERSUS THE MANUFACTURER Dr. Mimi Kaplan Director, Institute for Standardization and Control of Pharmaceuticals, Pharmaceutical Administration, Ministry of Health, Jerusalem, Israel
	10:50 – 11:10 IMPURITIES IN DRUG ANALYSIS: KNOWNS AND UNKNOWNS Dr. Bianca Avramovitch Associate Director, Global Generics R&D Analytical Technologies, Teva Pharmaceutical Industries, Jerusalem, Israel
	11:10 – 12:15 ASK THE REGULATOR: ANSWERS TO FAQ Dr. Moheb M. Nasr Director, Office of New Drug Quality Assessment, Center for Drug Evaluation and Research (CDER), FDA, USA