Summit of Heads of Medicines Regulatory Agencies Symposium

Time/Date:10:00-17:45, Oct.27,2017 Venue:Kyoto International Convention Center Hosts: Ministry of Health, Labour and Welfare, Pharmaceuticals & Medical Devices Agency, Kyoto Prefecture and DIA Japan Endorsement:JPMA and JFMDA

From October 23 through October 26, 2017, the Summit of Heads of Medicines Regulatory Agencies and meeting of the International Coalition of Medicines Regulatory Authorities (ICMRA) will convene for the first time in Japan, at the Kyoto International Conference Center. This “Kyoto Meeting” will bring together regulatory authorities from more than 30 countries and regions around the world, including the United States, Europe, China, Brazil, and Japan. A main topic will be innovation in pharmaceuticals, medical devices, and regenerative medicine. Participants will exchange viewpoints on a variety of topics including future of relevant regulation, review processes, postmarketing surveillance, stable product supply, and risk management.

The Kyoto Meeting is not open to the public, but following completion of the closed meeting, on October 27, a one-day symposium will be offered to provide an early report of the results of the Summit. This is the first time that a public symposium has been offered in conjunction with this type of regulatory summit conference, and is also the first time for representatives of regulatory authorities from so many countries to convene a summit conference in Japan.

In addition to providing a "flash report" about the results of the Kyoto Meeting, representatives from a variety of countries and industries will discuss innovative technological developments and their practical applications, both current status and future expectations, and will discuss how the various national regulatory authorities address technological development and what challenges can be expected. There will also be a not-to-be missed presentation by Professor Shinya Yamanaka, Nobel laureate. The executive committee looks forward to seeing broad participation in this truly unique opportunity.

What’s New

  • The number of registrants has already exceeded 1,000.
    If you have not registered yet please register as soon as possible.
  • Aug. 10, 2017 Please click here to download the program of Summit Symposium.
  • Aug. 10, 2017 Official website opened.

■ Overview (Featured Speakers)

  • Morning:

For the Practical Application of Innovative Technology

Primary speakers:
  • Shinya Yamanaka, MD, PhD, Director, Center for iPS Cell Research and Application (CiRA), Kyoto University
  • Guido Rasi, MD, Executive Director, European Medicines Agency (EMA)
  • Representatives of regulatory agencies and industry
  • Afternoon:

How the Various National Regulatory Authorities Approach Technological Innovations and What Challenges Can Be Expected

- Focusing primarily on results from the 12th Summit of Heads of Medicines Regulatory Agencies and International Coalition of Medicines Regulatory Authorities (ICMRA) Meeting -

Primary speakers:
  • Tatsuya Kondo, MD, PhD, Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA)
  • Kazuhiko Mori, MSc, Councilor for Pharmaceutical Affairs, Minister’s Secretariat, Ministry of Health, Labour and Welfare (MHLW)
  • Ian Hudson, MD, FFPM, FRCP, Chief Executive; Medicines and Healthcare products Regulatory Agency (MHRA) / ICMRA Chair
  • Representatives of the Summit of Heads of Medicines Regulatory Agencies and of the ICMRA authorities