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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

Senior Director for International Programs, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Nakashima joined Pharmaceutical and Food Safety Bureau of Ministry of Health, Labor, and Welfare (MHLW) in 1992. He spent his career in the international field such as at WHO and OECD, not only in the domestic field. He worked as International Planning Director since September... 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
K2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Regulatory Science
  • Tags Session