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Session 4 / Venue 1: The Future of ICH ~ (English Language Only)
Session Chair(s)
Akira Kawahara, PHD, MPHARM, RPH
(JPMA), Japan
Nobumasa Nakashima
Professor
Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Japan
Through its 20 years’ activities, ICH finalized more than 70 guidelines, and many countries other than Japan, the US and Europe are getting to make use of those guidelines. In addition, activities of ICH have been increasing its importance increasingly in the world where science and technology is progressing remarkably and development, supply and sales of medicinal products are globalizing. Taking into account such circumstances, ICH members discuss subjects such as the governance of ICH including its membership, new topics to be considered at ICH to revitalize activities, maintaining transparency, and promoting globalization of ICH activities. In this session, representatives from Japanese, US and European regulatory agencies and from ICH industry will give presentations on the current and future activities of ICH and international cooperation from their points of view, and discuss the future shape of ICH. Discussion time is held at the end of the session.
Speaker(s)
Future Activity of ICH from MHLW/PMDA’s Point of View
Naoyuki Yasuda, MSC
Pharmaceuticals and Medical Devices Agency, Japan
Future Activity of ICH From the FDA Point of View
Theresa Mullin, PHD
FDA, United States
Associate Center Director - CDER
Future Activity of ICH from the EU Point of View
Emer Cooke, MBA, MSC
European Medicines Agency, Netherlands
Chair, ICMRA; Executive Director
The Future of ICH – Industry Perspective
Peter Honig, MD, MPH, FACP
Advisor and Board Member, United States
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