Report of the PMDA-ATC Pharmacovigilance Seminar 2025
The PMDA held the “PMDA-ATC Pharmacovigilance Seminar 2025“ from February 26 to 28. This seminar was intended for officials of overseas regulatory agencies. It was attended by 28 participants from Bangladesh, Brazil, Brunei Darussalam, Chinese Taipei, Egypt, Indonesia, Malaysia, Mongolia, Peru, the Philippines, Sri Lanka, Thailand, Turkey, Uzbekistan, and Vietnam.
The seminar opened with remarks by Dr. KONDO Emiko, Senior Executive Director of PMDA, Director of the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs, followed by Dr. TANAKA Taihei, Office Director of Office of Pharmacovigilance One and senior coordinator of this seminar.
On the first day, lectures on “Overview of post-marketing drug safety in Japan,” “Outline of RMP”, “Development and update of RMP,” “Evaluation of RMP” and “Overview of post-marketing drug safety, RMP in EU” were provided. During the country introduction, representatives gave presentations on post-marketing regulatory systems in each country.
On the second day, a case study on “ADR Case Evaluation/Identification of safety specification” was provided. The participants were divided into groups and intensively discussed each case study. Lectures on “Communication of Safety Risk Information to Patients and Healthcare Professionals,” “End-to-end Labeling including CCDS Labeling Principles, Electronic Labeling Initiatives, Patient Centric Labeling/Health Literacy” and “Use of Published Safety Information at Clinical Sites” were provided.
On the final day, case studies on “Risk Management Plan” and “Pharmacovigilance Methods (Signal Detection)” and a lecture on “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 Keio University and industry also shared their expert knowledge and comments with participants, which contributed to this meaningful seminar. (See the program for details[126KB])
This event was concluded with speeches from Dr. KONDO Emiko, followed by Dr. TANAKA Taihei. As a token of active participation in the seminar, the digital certification of Open Badge was given to the participants.
Photos and participant comments
Comments from the participants:
- A great program to share information regarding pharmacovigilance activities.
- I really enjoyed the seminar and group work. This seminar enabled me to learn from PMDA and other countries' pharmacovigilance system.
- It was a well-organized seminar with a great set of speakers.
- Sharing information with the team and considering guidelines and regulation reviews for better practice.
- We plan to implement a similar risk minimizing effort as being undetaken by PMDA.
