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Wednesday, June 27 • 2:00pm - 3:15pm
#373: PMDA Town Hall

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-670-L04-P; CME 1.25; IACET 1.25; RN 1.25

During this forum, PMDA will share its activities to promote high-quality, innovative medical research and clinical trials meeting or exceeding international standards as well as its advocacy for the application of “Big Data” in medical practice. PMDA will present the latest details of regulatory aspects regarding its three primary services (review, safety, and the adverse event relief system (the “PMDA Safety Triangle”)) in addition to updates on its advanced product review system, regulatory capacity building activities, and international collaborations.

Learning Objectives

Discuss the latest information on Japanese regulatory initiatives and regulations; Identify how to update SAKIGAKE designation, MID-NET projects, etc. which were introduced in the PMDA Town Hall session in DIA the previous year.

Chair

Toshiyoshi Tominaga, PhD

Speaker

Recent Regulatory Topics and International Cooperation of MHLW
Kazuhiko Mori, MSc

PMDA’s Regulatory Science and Innovation
Tatsuya Kondo

Real-World Data Utilization: A New Approach to Pharmacovigilance
Shinobu Uzu, MSc


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 →
avatar for Kazuhiko Mori

Kazuhiko Mori

Councilor for Pharmaceutical Affairs, Minister’s Secretariat, Ministry of Health, Labour and Welfare (MHLW)
Kazuhiko Mori, MSc., is currently Councilor for Pharmaceutical Affairs, Minister’s Secretariat of the Ministry Health, Lobour and Welfare (MHLW). Mr. Mori has led many of MHLW/PMDA’s drug initiatives. He contributed to introduce new approaches to drug safety regulation including... Read More →
avatar for Toshiyoshi Tominaga

Toshiyoshi Tominaga

Associate Executive Director (for International Programs), Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tominaga is Associate Executive Director for International Programs. He supervises the overall strategy and conduct of international operations by PMDA. He joined MHLW after acquired PhD from Faculty of Pharmaceutical Sciences, the University of Tokyo. As a career official, he... Read More →
avatar for Shinobu Uzu

Shinobu Uzu

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA)
Mr. Shinobu Uzu is Associate Executive Director, PMDA since April 2018. As Chief Safety Officer, PMDA, he was responsible for post-market surveillance and GMP/QMS audit of pharmaceuticals, medical devices regulated by Pharmaceuticals and Medical Devices Law until March 2018. Mr. Uzu... Read More →

Wednesday June 27, 2018 2:00pm - 3:15pm
Room 205AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum