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2022 ISPE Annual Meeting & Expo

SES108a - How to Use EMA Q&A and PIC/S Annex 2 to Identify and Defend a Strategy for Starting Materials: Perspectives from the Ex-Chairperson of PIC/S Annex 2 WG and a former EMA IWG representative

Oct 31, 2022 1:45pm ‐ Oct 31, 2022 3:15pm


Francesco will discuss how to use EMA Q&A and PIC/S Annex 2 to identify and defend a strategy for starting materials with reference to plasmids and vectors and why it's commercially beneficial to go higher at an early strategy in terms of quality. This presentation will have an interactive simulation with the help of the participants.


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