Agenda:

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08:30- 09:00 Registration

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09:00-09:15 Opening remarks: PDA President Benny Klener, Teva

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09:15-10:00 European regulations and Agencies

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10:00-10:45 European Inspections

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10:45-11:00 Coffee Break

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11:00-11:45 How european Inspections are preformed

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11:45-12:30 How to prepare best for european inspections

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12:30-13:30 Lunch

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13:30-15:00 How to prepare a PIC Site Master File

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15:00-15:15 Coffee Break

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15:15-17:00 Workshop preparation of a Site Master File for a sample company

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Questions and answers

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Dr. Joerg Neuhaus is currently the Governmental Director on Pharmacy for the German Inspectorate.
He is also the GMP- inspector/compliance officer for medicinal products, biologics, blood and blood derived products for third party inspections. He has served as production director for 3M Medica GmbH, Germany and also served as a research and development director in the development of all dosage forms for E. Scheurich Pharmwerk, Germany.
Dr. Neuhaus has a Ph.D. in Industrial Pharmacy from the University of Bonn and holds an M.Sc from the University of Bonn. He has special expertise in Biological Products such as bacterial and viral vaccines, as well as conventional medicinal products both in sterile and non-sterile dosage forms.
He is also a specialist in validation and inspections.

Registration Fees: Memebers – 1125 NIS
Non-Members – 1320 NIS (includes membership through 2004)For Registration Form Please Click here (word doc.)

Click here for more information About the PDA For more information or directions, contact Eilat at Forum Scientific Education Tel: 08-9409085
Fax: 08-9409086 E-mail: forum_co@netvision.net.il site: www.forumsci.co.il