CONTEXT

With the globalization, continuous threat of infectious diseases outbreak can no longer be seen as an issue of just a single country or some countries but it requires the attention of the global community. The COVID-19 pandemic made it evident that having a robust medical product research and development (R&D) system is an essential part of achieving health security. International cooperation plays a major role as a catalysator in this development process.
This symposium, a collaboration between the PMDA (Pharmaceuticals and Medical Devices Agency) of Japan and ARISE (ARO Alliance in ASEAN and East Asia), will discuss how countries in Asia can work together to cultivate a conducive environment for medical R&D through regulatory harmonization, acceleration of First patient in and utilization of new tools for clinical research conduct.

OBJECTIVES

  • Update information of the latest regulatory strategy in medical R&D
  • Understand regulatory issues encountered by researchers, good practices in clinical trials conduct in each country and possible solutions to resolve the issues
  • Introduce the latest tools/approaches that accelerate clinical trials and regulatory approvals
  • Discuss efforts to address barriers and to accelerate First patient in and approvals in Asia, as well as how academia, regulatory bodies, and industry can work together
Free Hybrid

Date

Thursday 20th July, 2023

Time

13:00-18:00 JST

The 2nd ARISE-PMDA Joint Symposium was successfully closed.

Language

Simultaneous Interpretation （Japanese and English）

Venue

BELLESALLE Jimbocho Annex, Tokyo, JAPAN

For online participants
Registration is now closed
For onsite participants
Registration is now closed

Registration will be closed when we reach the maximum or full capacity of the venue.
We will take infection control measures as necessary on the day of the event and ask all participants to understand and cooperate.

Co-Organizors

Sponsors

OPENING

  1. 13:00-13:05Announcements from secretariat
    Sifa Muchanga, MD, PhD
    Regional Manager, Department of International Trials, CCS, NCGM, Japan
  2. 13:05-13:10Opening remarks
    Norihiro Kokudo, MD, PhD
    President, NCGM, Japan

"Latest regulatory strategy in medical research and development"

  1. 13:10-13:30Developing the Asian clinical research collaboration through the ARISE network activities
    Tatsuo Iiyama, MD
    Director, Department of International Trials, CCS, NCGM, Japan
  2. 13:30-13:50Cooperation for patients in Asia
    Junko Sato, MD, PhD
    Director, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  3. 13:50-14:10Regulatory strategies to achieve the 100 days mission (Online)
    Adam Hacker, PhD
    Head of Global Regulatory Affairs, Coalition for Epidemic Preparedness Innovations (CEPI)

"Regulatory issues surrounding clinical trial in Asia"

Chairs

Kinue Nishioka, BPharm, MSc, PhD
Division Director, Division of Asia II, Office of International Programs, PMDA, Japan
John Mark S. Velasco, MD, MPH, Msc (Clinical Trials), DTM&H
Research Associate Professor, Institute of Molecular Biology and Biotechnology, National Institute of Health, University of the Philippines, Manila (NIH-UPM), The Philippines

This session will focus on clarifying the regulatory issues in drug development. Speakers will address regulatory issues in each jurisdiction and in Asia from researcher's point of view, the lessons learned from their experiences in clinical trials conduct and potential solutions to be proposed.


  1. 14:10-14:25Navigating Clinical Trials in Asia: A New Landscape and Horizon
    Hasniza Zaman Huri, PhD, M. Clin Pharm, B. Pharm
    Dean, Faculty of Pharmacy, Professor of Clinical Pharmacy & Pharmacy Practice, Universiti Malaya
    Former Director/ Head, Clinical Investigation Centre (CIC), Universiti Malaya Medical Centre (UMMC) Malaysia
  2. 14:25-14:40Experiences of WHO Solidarity Trial in the Philippines
    Marissa Alejandria, MD, MSc, FPCP, FPSMID
    Director, Institute of Clinical Epidemiology, National Institutes of Health University of the Philippines Manila, The Philippines
  3. 14:40-14:55Clinical Trial for COVID-19 vaccine development
    Natsuko Oda, MSc
    Vice President, Clinical Research Department, Drug Development and Regulatory Science Division Shionogi & Co., Ltd., Japan
  4. 14:55-15:00QA
  5. 15:00-15:05Break

"First patient in Asian clinical trials"

Chairs

Tang Sia Chin, BPharm, MRes
Senior Principal Assistant Director, Investigational Product Evaluation and Safety Section, National Pharmaceutical Regulatory Agency (NPRA), Malaysia
Melva Louisa, BPharm, PhD
Research Coordinator, Department of Pharmacology, Faculty of Medicine, Universitas Indonesia, Indonesia

This session will focus on issues that cause the delay of First patient in (FPI). Speakers from academia and industry will share about their experience on how they could accelerate FPI whilst the Regulatory Authorities will share the efforts that have been made to improve Investigational New Drug review.


  1. 15:05-15:10Barriers/challenges to FPI in Southeast Asian countries (a comparison table)
    Marlinang D. Siburian, Mbiomed
    Regional Manager, Department of International Trials, CCS, NCGM, Japan
  2. 15:10-15:25Efficient process for IND review in Japan
    Miwa Kanematsu, MPH
    Principal Coordinator, Office of International Programs, PMDA, Japan
  3. 15:25-15:40Experiences of SICRES to accelerate FPI in Thailand
    Winai Ratanasuwan, MD, MPH, PhD
    Director of Siriraj Institute of Clinical Research, Siriraj Faculty of Medicine, Mahidol University, Thailand
  4. 15:40-15:55Accelerating Clinical Trial: Bio Farma Experience in COVID-19 Vaccine Development
    Rini Mulia Sari, MD
    Vice President of Surveillance and Clinical Research, Bio Farma Company, Indonesia
  5. 15:55-16:00QA

"Utilization of new tools & approaches in clinical trials"

Chairs

Akanid Wapeewuttikorn, BPharm, MSc
Pharmacist, Senior Professional Level, Medicines Regulation Division, Food and Drug Administration, Thailand
Hanis Hafizah Ismail, MBBS, BS
Science Officer, Head of Research Unit, Clinical Investigation Centre (CIC), Universiti Malaya Medical Centre (UMMC), Malaysia

Recently innovative study designs and new technologies that enables study to be conducted remotely or to assess multiple interventions have been developed. However, due to its novelty, studies that adopt these innovations may experience longer and more complicated review process. This session will focus on what is required for reviews and approvals of clinical trials using these innovative study designs and tools. Speakers will share their experience in utilizing these innovations and how to better utilize new technologies to implement new trials design under the ARISE consortium.


  1. 16:00-16:15Guidance on Decentralized Clinical Trials (DCT)
    Ahmad Izwan Bin Abdul Rani, BPharm, MSc
    Senior Principal Assistant Director, Good Clinical Practice (GCP) & Good Laboratory Practice (GLP) Section, NPRA, Malaysia
  2. 16:15-16:30Experience of REMAP-CAP Platform Trial (Pre-recorded video)
    Hiroki Saito, MD, MPH
    Assistant Professor, Department of Emergency and Critical Care Medicine, St. Marianna University School of Medicine, Japan
  3. 16:30-16:45Current status and expectation of DCT in Japan ~ from the industry stand point~
    Takao Okame, MS
    Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), Japan
  4. 16:45-16:50QA
  5. 16:50-17:00Break

PANEL DISCUSSION

Chairs

Junko Sato, MD, PhD
Director, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Wataru Sugiura, MD, PhD
Director, Center for Clinical Sciences, NCGM, Japan

  1. 17:00-17:50Theme:
    How academia, regulators and industry can work together to address barriers to accelerate FPI and approval in Asia
    Panelist:
     Adam Hacker, PhD
     Marissa Alejandria, MD, MSc, FPCP, FPSMID
     Miwa Kanematsu, MPH
     Rini Mulia Sari, MD
     Akanid Wapeewuttikorn, BPharm, MSc
     Ahmad Izwan Bin Abdul Rani, BPharm, MSc
     Hiroki Saito, MD, MPH
  2. 17:50-17:55Closing Remarks
    Hiroyuki Arai, PhD
    Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  3. 17:55-18:00Announcements

Representatives of NCGM 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)

For online participants
Registration is now closed
For onsite participants
Registration is now closed

Contact

The 2nd ARISE-PMDA Joint symposium for Asian Clinical Trials

E-mail: arise_symposium@event-info.jp