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Thursday, February 7 • 10:45 - 11:45
#S0906: ICH Info Day – Part 1

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Component Type: Session

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.


Petra Doerr, PharmD, RPh


Petra Doerr, PharmD, RPh

What’s New in ICH? Membership/Implementation/Training
Lenita Lindström-Gommers, LLM

Continuous Manufacturing Q13
Wendy L Zwolenski-Lambert, MSc

avatar for Petra Doerr

Petra Doerr

Deputy Executive Director, Swissmedic
Since January 2014 Head of Communication and Networking and Deputy Executive Director at Swissmedic, Swiss Agency for Therapeutic Products. Oversees the international cooperation with other agencies and international organisations. Member of the ICH Management Committee & Vice-chair... Read More →
avatar for Lenita Lindström-Gommers

Lenita Lindström-Gommers

ICH Assembly Chair and Senior Expert, European Commission, European Commission
Lenita Lindström-Gommers is a Senior Expert in the Directorate General for Health and Food Safety (DG SANTE) in the European Commission where she is responsible for international relations in the field of pharmaceuticals. Her main work relates to ICH where she was closely involved... Read More →
avatar for Wendy Zwolenski-Lambert

Wendy Zwolenski-Lambert

Director, Regulatory Affairs CMC Strategy and Policy, Novartis Pharma AG, Switzerland
Wendy Zwolenski-Lambert Wendy Zwolenski-Lambert is the Efpia topic lead on the ICH Q13 Continuous Manufacturing Expert Working Group. Following a decade working in medical devices and drug delivery systems, she moved to biopharmaceutical manufacturing of monoclonal antibodies. She... Read More →

Thursday February 7, 2019 10:45 - 11:45 CET
K1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria