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16th DIA Japan Annual Meeting 2019

Delivering Rational Medicine for All People in the Globe


[S06] A Solution for Patients and Healthcare Providers: a New Trial in Pharmacovigilance

Session Chair(s)

Shinichi  Nishiuma, MD

Shinichi Nishiuma, MD

  • Executive Director, Head of Medical Affairs, Japan
  • Celgene K.K., 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)

Kotonari  Aoki, MS

Between PV for Regulatory Compliance and PV for Patients

Kotonari Aoki, MS

  • Head of Real World Data Science Dept. Drug Safety Div.
  • Chugai Pharmaceutical Co., Ltd., Japan
Hideo  Sakamoto

Framework to Enhance the Quality of Re-Examination Applications – Emphasize Scientific Aspects in PMS Planning and Execution –

Hideo Sakamoto

  • Novartis Pharma K.K., Japan
Nobutomo  Matsui

PV by utilizing RWD and mHealth

Nobutomo Matsui

  • RWD Consulting Senior Principal
  • IQVIA Solutions Japan K.K. , Japan
Kanae  Kobayashi

Patient ADR Reporting of Drugs

Kanae Kobayashi

  • Reviewer
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan