A Special Session
will take place in Hall B
on Wednesday, January 23rd, 2008
between 10:30 – 12:15 am
With Dr. Moheb M. Nasr
Director, Office of New Drug Quality Assessment
Center for Drug Evaluation and Research (CDER) FDA, USA 

Isranalytica 2008 attendents will have the opportunity to present questions on general issues related to CMC, file applications, FDA policies on pharmaceutical topics and related regulatory issues to one of the more influential FDA experts and to receive, on the spot, insightful answers refering to the ratio and motivation for regulatory activities with reference to general trends in FDA regulations.
We hope that some of the questions will initiate open discussion on relevant pharmaceutical regulation policy subjects.

Participants wishing to present an invited question are encouraged to send their question/s to Dr. Raphy Bar, the session moderator (rbar@netvision.net.il)

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