Summit of Heads of Medicines Regulatory Agencies Symposium was held successfully.
We appreciate large attendance at the symposium.
Date
Friday, October 27th, 2017
Venue
Kyoto International Conference Center, Japan
Host
Ministry of Health, Labour and Welfare (MHLW), Pharmaceuticals and Medical Devices Agency (PMDA), Kyoto Prefecture and DIA Japan
Summary
From October 23 through October 26, 2017, the international Summit of Heads of Medicines Regulatory Agencies and the meeting of the International Coalition of Medicines Regulatory Authorities (ICMRA) were held for the first time in Japan, at the Kyoto International Conference Center. This “Kyoto Meeting” brought together 89 participants in total, including regulatory authorities from 29 countries and regions around the world. The main topic was innovation in pharmaceuticals, medical devices, and regenerative medicine. The participants exchanged their views on a variety of topics including future of relevant regulations, review processes, postmarketing surveillance, stable product supply, and risk management.
The Kyoto Meeting was not open to the public, but following completion of the closed meeting, on October 27, a one-day symposium was held to provide a flash report of the results of the Summit, and about 1,500 people participated in the symposium as audiences. This was the first time that a public symposium was held in conjunction with this type of regulatory summit conference, and was also the first time for the 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 gave presentations on innovative technological developments and their practical applications, both current status and future expectations, and discussed how the various national regulatory authorities address technological development and what challenges could be expected. There was also a memorable presentation by Professor Shinya Yamanaka, the Nobel laureate.
Program
| WELCOME AND OPENING REMARKS | ||||||||||||
Overall Host Ko Sekiguchi, MBA Director, DIA Japan |
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| Organizer Shinji Miyamoto Director General of Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare (MHLW) |
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| Host Keiji Yamada Governor, Kyoto Prefecture |
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| Industry Representative Yoshihiko Hatanaka President, the Japan Pharmaceutical Manufacturers Association (JPMA) |
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| Recent Progress in iPS Cell Research and Application Shinya Yamanaka, MD, PhD Director, Center for iPS Cell Research and Application (CiRA), |
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| EU’s Innovative Medical Technology and EMA’s Measures Guido Rasi, MD Executive Director, European Medicines Agency (EMA) |
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| US 21st Century Cures Act - Challenge of FDA - [Video Letter] Scott Gottlieb, MD Commissioner, US Food and Drug Administration (FDA) |
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| For Early Access of Innovative Medicines to Patients Yoshihiko Hatanaka President, the Japan Pharmaceutical Manufacturers Association (JPMA), Chief Executive Officer and President, Astellas Pharma, Inc. |
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| For Early Access of Innovative Medical Devices to Patients Masaya Watanabe, MSc Chairman, The Japan Federation of Medical Devices Associations (JFMDA) |
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Results of the 12th Summit of Heads of Medicines Regulatory Agencies Tatsuya Kondo, MD, PhD Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA) |
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| Results of the ICMRA Meeting Ian Hudson, MD, FFPM, FRCP Chief Executive; Medicines and Healthcare products Regulatory Agency (MHRA) / |
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| Report of Workshops of the ICMRA [I]: Supply Chain Integrity Guido Rasi, MD Executive Director, European Medicines Agency (EMA) |
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| Report of Workshops of the ICMRA [II]: Pharmacovigilance Larry Kelly, PhD First Assistant Secretary, Therapeutic Goods Administration (TGA) |
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