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[S06] A Solution for Patients and Healthcare Providers: a New Trial in Pharmacovigilance
Session Chair(s)
Shinichi Nishiuma, MD
Executive officer, Chief Medical Officer
Aculys Pharma Inc,, Japan
Under recent drastic change of phamacovigilance approach, some proactive activities or new business models are explored to leverage safety data from post-marketing pharmaocovigilance to maximization of the benefit for patients and health care providers. In this session, we will discuss how these new patient centric approaches are positively impacting on creation of new evidence which should be useful for patients and health care providers.
Speaker(s)
Between PV for Regulatory Compliance and PV for Patients
Kotonari Aoki, MS
Chugai Pharmaceutical Co., Ltd., Japan
Head of Real World Data Science Dept. Drug Safety Div.
Framework to Enhance the Quality of Re-Examination Applications – Emphasize Scientific Aspects in PMS Planning and Execution –
Hideo Sakamoto
Novartis Pharma K.K., Japan
PV by utilizing RWD and mHealth
Nobutomo Matsui
IQVIA Solutions Japan K.K. , Japan
Vice President, Real World Solutions
Patient ADR Reporting of Drugs
Kanae Kobayashi
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer