Good Manufacturing Practice - Annex 13

Our GMP courses cover the rules that apply to the manufacture and labelling of experimental IMPs in Europe. The Annex 13 rules were brought in for several reasons including to help protect the trial subjects, ensure the IMP can be tracked and traced, and to provide a mechanism for identifying IMP in the case of emergency unblinding.

WHITEHALL TRAINING's 3-hour GMP-Annex 13 course takes the learner through the rules step-by-step and is essential reading for all sponsors carrying out trials in the EU - especially those from outside Europe. Just click on the language you need for more information and to order...  

GMP - Annex 13 (English)

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GMP - Annex 13 (Bulgarian)

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GMP - Annex 13 (German)

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GMP - Annex 13 (Hungarian)

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GMP - Annex 13 (Polish)

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GMP - Annex 13 (Romanian)

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GMP - Annex 13 (Russian)

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