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Summit of Heads of Medicines Regulatory Agencies Symposium

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

(click here)

WELCOME AND OPENING REMARKS

Overall Host
Ko Sekiguchi, MBA

Director, DIA Japan

Organizer
Shinji Miyamoto

Director General of Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare (MHLW)

Host
Keiji Yamada

Governor, Kyoto Prefecture

Industry Representative
Yoshihiko Hatanaka

President, the Japan Pharmaceutical Manufacturers Association (JPMA)

MORNING SESSION
Innovative Technology and Its Launch into Market
 
Recent Progress in iPS Cell Research and Application
Shinya Yamanaka, MD, PhD

Director, Center for iPS Cell Research and Application (CiRA),
Kyoto University / Professor, Kyoto University

EU’s Innovative Medical Technology and EMA’s Measures
Guido Rasi, MD

Executive Director, European Medicines Agency (EMA)

US 21st Century Cures Act - Challenge of FDA - [Video Letter]
Scott Gottlieb, MD

Commissioner, US Food and Drug Administration (FDA)

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.

For Early Access of Innovative Medical Devices to Patients
Masaya Watanabe, MSc

Chairman, The Japan Federation of Medical Devices Associations (JFMDA)

 
AFTERNOON SESSION
Measures and Challenges of Pharmaceutical Regulatory Authorities, Mainly Based on the Results of the 12th Summit and ICMRA Meeting

Results of the 12th Summit of Heads of Medicines Regulatory Agencies
Tatsuya Kondo, MD, PhD

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA)

Results of the ICMRA Meeting
Ian Hudson, MD, FFPM, FRCP

Chief Executive; Medicines and Healthcare products Regulatory Agency (MHRA) /
ICMRA Chair

Report of Workshops of the ICMRA [I]: Supply Chain Integrity
Guido Rasi, MD

Executive Director, European Medicines Agency (EMA)

Report of Workshops of the ICMRA [II]: Pharmacovigilance
Larry Kelly, PhD

First Assistant Secretary, Therapeutic Goods Administration (TGA)

Report of Workshops of the ICMRA [III]: Crisis Management
Jarbas Barbosa da Silva Jr, MD, PhD

Director-President of National Health Regulatory Agency (ANVISA)

Pharmaceutical Regulatory Activities of WHO
Emer Cooke, MBA

Head of Regulation of Medicines and other Health Technologies, World Health Organization (WHO)

Global Cooperation on Regulatory Authorities and Japan’s Activities
Kazuhiko Mori, MSc

Councilor for Pharmaceutical Affairs, Minister’s Secretariat, Ministry of Health, Labour and Welfare (MHLW)

 
PANEL DISCUSSION
International Cooperation on Pharmaceutical Regulatory Authorities
 
Session co-chairs
Tatsuo Kurokawa, PhD

Former DIA President

Lorraine Nolan, PhD

Chief Executive, the Health Products Regulatory Authority (HPRA)

Panelists
Kazuhiko Mori, MSc

Councilor for Pharmaceutical Affairs, Minister’s Secretariat,
Ministry of Health, Labour and Welfare (MHLW)

Dara Corrigan, JD

Acting Deputy Commissioner, US Food and Drug Administration (FDA)

Guido Rasi, MD

Executive Director, European Medicines Agency (EMA)

Jürg H. Schnetzer

Executive Director, Swissmedic

Supriya Sharma, MD, MPH, FRCPC

Chief Medical Advisor, Health Canada (HC)

 
CLOSING REMARKS
Masaya Watanabe, MSc

Chairman, The Japan Federation of Medical Devices Associations (JFMDA)

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan

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