戻る Agenda
S18 : We've Come This Far! Implementation of Automation of Safety and Regulatory Authority Initiatives
Session Chair(s)
Hirotami Ohara
Head of PV Operations, Japan PV Lead in TCBI, PV Operations Head, Sanofi K.K., TransCelerate / Sanofi K.K., Japan
Speaker(s)
Oeystein Kjoersvik, MS, MSC
Technology Auditor and Quality Projects Lead, Merck Sharp & Dohme LLC, Czech Republic
Considerations for Validating Artificial Intelligence (AI)-based Static Systems in Pharmacovigilance
Inderdip Singh Khorana
Sr. Director, Safety, Regulatory & Quality Technology Solutions , IQVIA Services Japan K.K., Japan
Automation of Safety Management Information Processing Operations using Advanced AI, ML, and NLP Technology
Kenji Kuramochi
Chief Safety Officer, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Initiatives by Regulatory Authorities for Operations of Processing Safety Management Information including ICSRs
Makoto Morita
Director, Safety Operation Management, Japan Drug Safety Unit, Japan Pharmaceutical Manufacturers Association (JPMA) / Pfizer Japan Inc., Japan