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Europa v10 ops file3/11/2024 the current applicable documents) and documents relevant to clinical trials authorised under Regulation (EU) No 536/2014, these documents will be listed in two separate pages on the Eudralex Volume 10 website. In order to make a distinction between documents applicable to clinical trials authorised under Directive 2001/20/EC (i.e. ![]() Additionally, new documents were prepared to cover new aspects introduced by the same Regulation. Volume 10 of the publication "The rules governing medicinal products in the European Union" contains guidance documents applying to clinical trials.Ī number of documents in Volume 10 are being revised and updated to bring them in line with the changes required by the Clinical Trials Regulation (EU) No 536/2014.
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