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Sakigake System: From Pilot to Permanent
Published Date: Dec 01, 2020Summary of revision of Japan’s Pharmaceutical Affairs Act (PMD-Act) issued in December 2019 focuses on improvement of systems from development to post-marketing and establishment of regulatory compliance systems to further trust in the healthcare community of Japan.
Author(s)
Akiko Ikeda
KalVista Pharmaceuticals Japan K.K.
Education Background: Graduated Tokyo University of Pharmacy and Life Sciences / Qualification: Licensed Pharmacist / CURRENT POSITION: Senior Manager of Policy Intelligence Department in Janssen Pharma K.K (Japan), A leader of Regulatory Sub Committee in PhRMA Japan, A member of Contents Committee in DIA Japan / SUMMARY OF PROFESSIONAL EXPERIENCE: 5 years of experiences at regulatory policy and intelligence; About 20 years of experiences at regulatory affair area including development for New drugs (NDA/ PMDA consultation); Started the carrier at Sankyo Co. (Currently Daiichi-Sankyo Co.) in 1986.