קטגוריה: החברה הישראלית לכימיה אנליטית (עמותה)
MEET THE REGULATOR

 

תאריך: 23 בינואר 2008
מיקום הקורס:  מלון דיויד אינטרקונטיננטל, תל אביב
שפת הקורס: עברית
משך הפעילות: יום לימודים מלא
שעות: 8:30 - 12:00
נקודות זכות: 0
מק''ט: 08187
 


A Special Session

will take place in Hall C
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 2008attendents 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

Session Chairman and Discussion Moderator: Dr. Raphy Bar

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