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Wednesday, February 6 • 16:45 - 18:00
#S0804: Update on PMDA’s Activities

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Component Type: Session

In this session, PMDA will share the latest details regarding its policies and initiatives and other related strategic directives. The goal of the session will be to keep participants informed of the agency’s handling of the most critical issues facing Japanese and global stakeholders. The session will also include time for Q&A.

Chair

Nobumasa Nakashima, PhD

Speaker

PMDA’s Regulatory Science and Innovation
Tatsuya Kondo, MD, PhD

Regulatory Updates – Facilitating Early Patient Access
Kenichi Mikami, MPharm

Real World Data Utilisation: PMDA’s Approach to Pharmacovigilance
Daisaku Sato, PhD, MPharm



Speakers
avatar for Tatsuya Kondo

Tatsuya Kondo

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tatsuya Kondo is Chief Executive of PMDA since 2008. He spent most of his career as a neurosurgeon after his graduation from the University of Tokyo in 1968. He has various experiences including a hospital doctor, a fellowship in Max-Planck Institute for brain tumor research... Read More →
KM

Kenichi Mikami

Office Director, Office of Review Management, Pharmaceuticals and Medical Devices Agency (PMDA)
Mr. Mikami has taken his position as Office Director of Office of Review Management, Pharmaceuticals and Medical Devices Agency (PMDA), Japan since July 2018. After he earned his master degree at Graduate School of Pharmaceutical Sciences, Tohoku University, Mr. Mikami joined Ministry... Read More →
avatar for Nobumasa Nakashima

Nobumasa Nakashima

Associate Executive Director for International Programs and Asia Training Centre, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Nakashima holds the position of Associate Executive Director for International Programs and Asia Training Centre (ATC) at PMDA since January 2020. Before this position, he had joined MHLW in April 1992, where he worked as Director of Office of International Regulatory Affairs... Read More →
DS

Daisaku Sato

Chief Management Officer & Associate Centre Director for Advanced Evaluation, Pharmaceuticals and Medical Devices Agency (PMDA)
Daisaku Sato is Chief Management Officer & Associate Centre Director for Regulatory Science, Pharmaceuticals and Medical Devices Agency (PMDA). From June 2016 to July 2018, he was Director, Pharmaceutical Safety Division, Pharmaceutical Safety and Environmental Health Bureau, the... Read More →


Wednesday February 6, 2019 16:45 - 18:00 CET
K2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  08 Regional Updates, Session
  • Featured Topics Regulatory Science
  • Tags Session