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ICH 30th Anniversary: Achievements and Future Prospects
Session Chair(s)
Amanda Roache, MS
Deputy Vice President, Science and Regulatory Advocacy , PhRMA, United States
This session will celebrate the key successes of the ICH Association in recognition of its 30th anniversary highlighting how the Association has evolved to respond to the increasingly global market and new advances in pharmaceutical development.
Learning Objective : Identify key accomplishments of the ICH Association since it was founded in 1990; Discuss how ICH guidelines have contributed to more efficient drug development and increased patient access to pharmaceuticals worldwide; Explain how the reforms completed in 2015 have expanded the global reach of ICH and increased participation from regulators and industry around the world.
Speaker(s)
MHLW/PMDA Perspective
Professor, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Japan
European Commission Perspective
ICH Assembly Chair and Senior Expert, European Commission, European Commission, Belgium
FDA Perspective
Associate Center Director - CDER, FDA, United States
IGBA Perspective
Chair, IGBA Science Committee; Consultant, Compliance, Quality & Sci Affairs, Dr. Reddy's Laboratories, United States
Panelist
, Advisor and Board Member, United States
Panelist
Director General, Biologic and Radiopharmaceutical Drugs Directorate, HPFB, Health Canada, Canada
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