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VL21CEMAR1/SES105 - Revision of EU GMPs Annex 1: What Impacts Can We Expect as an Industry?


‐ Mar 16, 2021 9:00am

Revision of EU GMPs Annex 1: What Impacts Can We Expect as an Industry? | 2020 saw the commenting of the draft Annex 1, which included many changes to the 2017 version. In this session, we will cover the commenting process both from the ISPE and the PHSS perspective. Selected topics will be discussed in detail. Based on the outcome of the session with regulators from the 2020 ISPE Annual Meeting, we will give an outlook on the implementation of the final guidance issued by EMA.