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ㆍ작성자 ㆍ작성일 2020-05-19 (화) 15:50 ㆍ첨부#1 EMA_CHMP_BWP_534898_2008_rev_1_corrigendum.pdf (210KB) (Down:5933) ㆍ조회: 4642   [바이러스 불활화] EMA_CHMP/BWP/534898/2008Rev.1 Title : Requirements for quality documentation concerning biological investigational medicinal products in clinical trials Reference number : EMA/CHMP/BWP/534898/2008 Rev. 1 corrigendum Description : This document addresses the specific documentation requirements on the biological, chemical and pharmaceutical quality of investigational medicinal product (IMP) containing biological/biotechnology derived substances. It applies to cases where no 'simplified IMP Dossier' is submitted. Source : EMA Homepage (https://www.ema.europa.eu/en)