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S18 : We've Come This Far! Implementation of Automation of Safety and Regulatory Authority Initiatives
Session Chair(s)
Hirotami Ohara
Japan PV committee Chair, TransCelerate / Japan PV Operations Head, Sanofi K.K.
TransCelerate / Sanofi K.K., Japan
Speaker(s)
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
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
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
Japan Pharmaceutical Manufacturers Association (JPMA) / Pfizer Japan Inc., Japan
Director, Safety Operation Management, Japan Drug Safety Unit