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ICH at 30 - What Will Come the Next 30 Years?
Session Chair(s)
Lenita Lindström, LLM
ICH Assembly Chair and Senior Expert, European Commission
European Commission, Belgium
ICH is celebrating its 30th Anniversary in 2020. DIA is happy to honour this important milestone by organising a roundtable discussion on ICH with key representatives who are closely involved in ICH activities – the purpose is to take stock of what has been achieved and look into the future of technical and scientific harmonisation and the role of ICH. After its start in 1990 as a collaboration between regulators and research-based pharmaceutical industry of 3 regions (EU, US and Japan), ICH has undergone a major reform that has opened up membership and transformed ICH into an international, global organisation that in 2019 comprised 16 Members and 32 Observers.
Speaker(s)
What prompted the setting up of ICH and have the initial objectives of ICH been met?
Fernand Sauer, PharmD, LLM
French Academy of Pharmacy; Former Executive Director EMA, France
Impact of 2015 reform; what further improvements for managing size and workload?
Theresa Mullin, PhD
FDA, United States
Associate Center Director - Strategic Initiatives, CDER
How has ICH benefited the patient, what more can be done in future (observership)?
Nobumasa Nakashima
Cabinet Office, Japan
Health Policy Director, National Healthcare Policy Secretariat
Benefits for other emerging regional harmonization projects (AMA), future role for WHO?
Emer Cooke, MBA, MSc
The European Medicines Agency, Netherlands
Executive Director, Chair, ICMRA
Key breakthroughs that ICH has brought to the industry; how to efficiently expand the ICH platform in the future.
Hironobu Hiyoshi, PhD
Japan Pharmaceutical Manufacturers Association (JPMA), Japan
Member of the ICH Management Committee and of the Assembly
Looking at 60 ICH guidelines: anything major missing from the multi-annual strategy?
Jörg Schläpfer, PhD
Swissmedic, Switzerland
Head of Management Services and International Affairs
How can ICH promote therapeutic innovation, now and in the future?
Pär Tellner, MPharm, MSc, RPh
EFPIA - European Federation of Pharmaceutical Industries and Associations, Belgium
Director, Regulatory, Drug development and Manufacturing
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