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Ariake Central Tower Hall and Conference

Nov 05, 2023 9:30 AM - Nov 07, 2023 6:00 PM

Ariake Central Tower 3F, 4F, 3-7-18 Ariake, Koto-ku, Tokyo, 135-0063 Japan

20th DIA Japan Annual Meeting 2023

Rebuilding Drug Development through Society 5.0: The Fusion of Knowledge and Technology that Transcends Time and Space

S18 : We've Come This Far! Implementation of Automation of Safety and Regulatory Authority Initiatives

Session Chair(s)

Hirotami  Ohara

Hirotami Ohara

Japan PV committee Chair, TransCelerate / Japan PV Operations Head, Sanofi K.K.

TransCelerate / Sanofi K.K., Japan

Speaker(s)

Oeystein  Kjoersvik, MS, MSc

Considerations for Validating Artificial Intelligence (AI)-based Static Systems in Pharmacovigilance

Oeystein Kjoersvik, MS, MSc

Merck Sharp & Dohme LLC, Czech Republic

Technology Auditor and Quality Projects Lead

Inderdip Singh Khorana

Automation of Safety Management Information Processing Operations using Advanced AI, ML, and NLP Technology

Inderdip Singh Khorana

IQVIA Services Japan K.K., Japan

Sr. Director, Safety, Regulatory & Quality Technology Solutions

Kenji  Kuramochi

Initiatives by Regulatory Authorities for Operations of Processing Safety Management Information including ICSRs

Kenji Kuramochi

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Chief Safety Officer

Makoto  Morita

Makoto Morita

Japan Pharmaceutical Manufacturers Association (JPMA) / Pfizer Japan Inc., Japan

Director, Safety Operation Management, Japan Drug Safety Unit

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