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ICH Info Day – Part 1
Session Chair(s)
Petra Doerr, PharmD, RPh
Director
European Directorate for the Quality of Medicines and Healthcare (EDQM), France
The International Council for Harmonisation (ICH) held its last meeting in Charlotte, NC, USA on 10-15 November 2018. Three years on from the reform of ICH, all organisational changes have been implemented, with the Charlotte meeting being illustrative of ICH’s steady evolution to a more global initiative. This is evidenced by the fact that ICH is now constituted by 16 Members and 28 Observers with harmonisation efforts ongoing in 25 Working Groups which currently involve over 600 experts. Participants will learn about the recent developments of the ICH Association both regarding strategic initiatives such as ICH’s approach to training and the implementation of ICH guidelines as well as regarding technical guidelines. Part 1 of the ICH Info Day includes a presentation describing the ICH focus on managing the continued efficiency of the ICH process and facilitating a harmonized implementation of ICH guidelines as well as a presentation of the recently agreed new quality topic, Q13 on Continuous Manufacturing.
Speaker(s)
Introduction
Petra Doerr, PharmD, RPh
European Directorate for the Quality of Medicines and Healthcare (EDQM), France
Director
What’s New in ICH? Membership/Implementation/Training
Lenita Lindström, LLM
European Commission, Belgium
ICH Assembly Chair and Senior Expert, European Commission
Continuous Manufacturing Q13
Wendy Zwolenski-Lambert, MSc
Novartis Pharma AG, Switzerland
Director, Regulatory Affairs CMC Strategy and Policy
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