Invitation to
PDA Discussion Meeting
Organized by Raphy Bar
On


הסכמי איכות בתעשיה הפרמצבטית
מק"ט: 11708P

Tuesday May 3, 16:00h
Lev Hakongressim, Weizmann Science Park, Ness Ziona

With:
Rachel Shimonovitz
Head of the inspectorate Institute for Standardization and control of pharmaceuticals, MOH
and
Hadar Amir
Qualified Person, Teva Israel

Quality Agreements or technical agreements are not only a good business practice but also a GMP requirement. They could involve a third –party manufacturer of an API or finishsed product, a second-party manufacturer, a raw material supplier, an excipient supplier, a contract testing laboratory or a stability storage facility. A main focus of an inspection by a regulatory agency is often about how the parties assign responsibilities, communicate between them and guarantee compliance with GMPs. All these issues will be highlighted in the settings of a GMP drug manufacturer and of an importer of drugs.

Program:

16:00 – 16:15

Opening Notes

Raphy Bar

16:15 - 17:00

Quality Agreement: A GMP Requirement
לקבלת המצגת אנא לחצו כאן

Rachel Shimonovitz
MOH

17:50 – 17:30

Break

 

17:30 – 18:00

Quality Agreement from the Perspective of an Importer

Hadar Amir
Teva Israel

18:00 – 18:30

Open Discussion

 

for map please click here

Participation:
International PDA members - 80 NIS
Non members - 160 NIS

Registration is mandatory, please register here

Organized & Produced by
Bioforum - Applied Knowledge Center
Lev Hakongressim, 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.org.il

 

 
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