• Date and Time
  • July 12, 2022, 15:00 to 18:00 （Japan time）Online workshop（Zoom）
    ARISE-PMDA joint symposium was successfully closed.
  • Registration
  • Pre-registration is required
  • Language
  • Simultaneous Interpretation （Japanese and English）

No Video, Image, or Audio Recording of Symposium Information ：

Recording, photographing, screenshotting or downloading of this symposium, as well as any unauthorized diversion of materials, is strictly prohibited.

Co-organized ：

National Center for Global Health and Medicine (NCGM) and Pharmaceuticals and Medical Devices Agency (PMDA)

Sponsors ：

ARISE Member Institutes,
Japan Agency for Medical Research Department (AMED), Japan Pharmaceutical Manufacturers Association (JPMA)

Objective
（Participants will be able to)

  • Establish cooperative relationships at staff level for PAPP in Asia
  • Familiarize with the functions of ARISE and the utilization of its network
  • Learn the key aspects of pharmaceutical regulations and regulatory systems for conducting clinical trials in Asia
  • Understand how each country manages to improve patient access to COVID-19 vaccines and therapeutics

Program

Opening remarks
JST
15:00 - 15:10

Dr. Norihiro Kokudo

President of NCGM

Session1

Introduction of ARISE

Chair: Dr. Yoichi Nakanishi, M.D., Ph.D

President, Kitakyushu City Hospital Organization
Program Supervisor: AMED Clinical Research and Clinical Trial Promotion Research Project

JST 15:10-15:30
1-1

ARISE roles in promoting clinical research

Dr. Tatsuo Iiyama

Director, DIT, NCGM

Session2

Promotion of ICH-GCP in Asia

Theme: "Initiatives and challenges in complying ICH-E6 for quality clinical trials"

Dr. Yoshiko Komuro, Ph.D

Inspection Director, Office of Non-clinical and Clinical Compliance, PMDA

JST 15:30 - 15:40
2-1

Outline of ICH E6 and efforts to promote E6 in Asia

Dr. Yoshiko Komuro, Ph.D

Inspection Director, Office of Non-clinical and Clinical Compliance, PMDA

JST 15:40 - 15:50
2-2

Initiatives for ICH E6 promotion in Vietnam

Nguyen Ngo Quang

Deputy Director, Technology and Training, Department of Science, MOH Drug Administration of Vietnam

JST 15:50 - 16:00
2-3

Initiatives for ICH E6 promotion in Indonesia

Prof. Dr. dr. Rianto Setiabudy, Sp. FK

Department of Pharmacology and Therapeutic Faculty of Medicine, Universitas Indonesia

JST 16:00 - 16:10
2-4

Expectations and challenges in conducting GCP-compliant clinical trials in Asia, based on the experience of Japanese companies

Mr. Masaaki Jitsu

Head of Study & Site Management Group 3 & RLE/HEOR Platform Manager, Bayer Yakuhin, Ltd. Research & Development Japan, Pharmaceuticals (Clinical Evaluation Expert Committee, Drug Evaluation Committee, JPMA)

JST 16:10 - 16:20
2-5

QA, Discussion

All

Session3

Panel Discussion: How to combat COVID-19

Theme: "Initiatives for early patient access to COVID-19 Pharmaceuticals by Industry, Government, and Academia"

Chair: Dr. Junko Sato, Director, Office of International Program, PMDA, and
Dr. Tatsuo Iiyama, Director, DIT, CCS, NCGM

JST 16:20 - 16:50
3-1

Perspectives of regulatory authorities

Ms. Yuriko Takemura

Coordinator, Office of International Program, PMDA

Dr. Iris Conela A. Tagaro

Medical Specialist III, Center of Regulation and Research, FDA Philippines

Dr. Zaril Harza Zakaria

Head of Investigational Product Evaluation and Safety Section, NPRA, Malaysia

Dr. Siti Asfijah Abdoellah

Director, Directorate of Drug Registration, Indonesia FDA

JST 16:50 - 17:00
3-2

Perspectives of academia

Dr. Sant Muangnoicharoen

Head of Clinical Pharmacology Research Unit, Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University

JST 17:00 - 17:10
3-3

Perspectives of pharmaceutical company

Dr. Norio Tamura

Vice President, Vaccine Business Department, Integrated Disease Care Division, Shionogi & CO., LTD.

JST 17:10 - 17:40
3-4

Panel Discussion "What can we do to make early patient access to COVID-19 vaccines and therapeutics possible? "

Panelists: PMDA, Philippine FDA, NPRA Malaysia, Mahidol University, IndonesiaFDA, Shionogi & CO., LTD.

Symposium Summary
JST
17:40 - 17:55

Dr. Wataru Sugiura, M.D., Ph.D

Director, Center of Clinical Sciences, NCGM

Closing Remarks
JST
17:55 - 18:00

Dr. Yasuhiro Fujiwara, M.D., Ph.D

PMDA President

Representatives of ARISE and PMDA

Dr. Norihiro KOKUDO

President,
National Center for Global Health and Medicine (NCGM)

Dr. Yasuhiro FUJIWARA

Chief Executive,
Pharmaceuticals and Medical Devices Agency (PMDA)

Assoc.Prof. Dao Xuan Co

Acting Director,
Bach Mai Hospital(BMH), Vietnam

Prof. Prasit Watanapa

Dean, Faculty of Medicine Siriraj Hospital (FMSH),
Mahidol University, Thailand

Dr. Wawaimuli Arozal

Director,
Department of Pharmacology and Therapeutic Pre Clinic, University of Indonesia (UI)

Dr. Eva Maria Cutiongco-de la Paz

Director, National Institute of Health,
The University of the Philippines Manila (UPM)

Prof. Hiroaki Shimokawa

Vice Dean, Graduate School,
International University of Health and Welfare (IUHW)

Prof. Dr. Irawan Yusuf

President,
Mochtar Riady Institute for Nanotechnology (MRIN)

Prof. Kenji Hirayama

School of Tropical Medicine and Global Health,
Nagasaki University

Prof. Ken Nakata

Director, Center for Global Health,
Osaka University Hospital