Agenda:

08:30-09:00 Registration
09:00-09:15 Introduction
Dr. Yael Libal-Weksler
Quality Systems Manager, BTG
09:15-10:00 Introduction to Medical Device Requirements Dr. Tamar Katsav
Program Leader, Physio-Logic
10:00-10:45
Risk Assessment for Combination Products
Ari Levin
Senior Quality and Regulatory expert, Physio-Logic
10:45-11:15 Coffee Break
11:15-12:00 Understanding Medical Device Single Audit Program (MDSAP)
Yael Goldbrener
Program Leader, Physio-Logic
12:00-12:45 Combination Product Guidelines in Europe
Adina Klein
Senior Manager Regulatory Affairs, BTG
12:45-14:00 Lunch
14:00-14:45 Combination Products in the US Dr. Hagit Marchaim
Regulatory Affairs and Drug Development Consultant (HMC)
14:45-15:30 Q&A panel with all participants

Note: the program and speakers are tentative and subject to change without prior notice.

Participation Fees:
PDA members - 850 NIS
Non members - 1100 NIS 

SKU: P20813

   

 

Organized & Produced by
Bioforum - Applied Knowledge Center
Golda Meir 3, Weizmann Science Park
P.O.B. 4034 Ness Ziona, Israel, 70400
Tel: 08-9313070
Fax: 08-9313071
E-mail: bioforum@bioforum.co.il
site: www.bioforum.co.il

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