Invitation to
PDA Discussion Meeting
Organized by Raphy Bar

הסכמי איכות בתעשיה הפרמצבטית
מק"ט: 11708P

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

Rachel Shimonovitz
Head of the inspectorate Institute for Standardization and control of pharmaceuticals, MOH
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.


16:00 – 16:15

Opening Notes

Raphy Bar

16:15 - 17:00

Quality Agreement: A GMP Requirement
לקבלת המצגת אנא לחצו כאן

Rachel Shimonovitz

17:50 – 17:30



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

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



        Home   l   About   l   Committee   l   Activities   l   Contact   l   Bioforum