APEC CoE Workshop: PMDA-ATC Pharmacovigilance Seminar 2026
The PMDA organized a seminar on pharmacovigilance for overseas regulators. Held in Tokyo, February 25 to 27, it served as a Center of Excellence (CoE) workshop as designated by the Asia Pacific Economic Cooperation, Regulatory Harmonization Steering Committee (APEC - RHSC). It was attended by 31 participants from Bangladesh, Brazil, Cambodia, Chile, Chinese Taipei, Egypt, India, Indonesia, Kazakhstan, Malaysia, Pakistan, Peru, Philippines, Sri Lanka, Thailand and Uzbekistan.
The seminar opened with welcome remarks by Dr. KONDO Emiko, Senior Executive Director of PMDA, and Director of PMDA-ATC, Mr. ICHIMARU Katsuhiko, Office Director, Office of Pharmacovigilance I and Senior Coordinator of the seminar, Dr. Shanthi Pal from WHO and Dr. Gerald J. Dal Pan from U.S. FDA.
On the first day, lectures on “Overview of post-marketing drug safety in Japan,” “Outline of RMP (Risk Management Plan) in Japan,” “Development and update of RMP,” and “Overview of post-marketing drug safety including REMS (Risk Evaluation and Mitigation Strategies) in US” started off the seminar. At the round table discussion, representatives gave presentations on post-marketing regulatory systems in their economies, with PMDA and Dr. Dal Pan commenting from their points of view.
On the second day, lectures on “Signal detection and use of AI in pharmacovigilance”, “End-to-end Labeling including CCDS Labeling Principles, Electronic Labeling Initiatives, Patient Centric Labeling/Health Literacy”, “GVP in Japan” and “Global PV initiative” were provided. The participants were divided into groups and intensively discussed a case study on “ADR Case Evaluation/Identification of Safety Specification”.
On the final day, a case study on “Risk Management Plan” and lectures on “Communication of Safety Risk information to Patients and Healthcare Professionals,” “Use of published safety information at clinical site”, “Pharmacovigilance Methods” and “Utilization of Real-World Data for Post-Marketing Drug Safety in PMDA” were provided.
Throughout this seminar, in addition to PMDA staff members, lecturers and facilitators from industry, WHO, U.S.FDA, Keio University and Tokyo Metropolitan government also shared their expert knowledge and comments with participants, which contributed to this meaningful seminar.
(see the program for details[183KB])
This event was concluded with speeches from Dr. Kondo, Mr. Ichimaru and Dr. Pal. All successful participants were awarded a digital certificate of attendance.
Lecturers and facilitators
Leadership and discussions
Comments from participants:
- The seminar is very well organized, and the topics are relatable with very knowledgeable speakers.
- Thank you for the very successful workshop, we had learnt a lot from this workshop.
- We have shared a lot of information from each other, changed insight and experience about the pharmacovigilance system.
- I will apply the knowledge learnt on causality assessment and risk communication at my work place, also provide training to other officers in my Pharmacovigilance department.
