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Applications are now open for regulatory officials
Seminar Overview
The APEC CoE Workshop: PMDA-ATC Pharmacovigilance Seminar 2027 is a training program for regulatory officials. It will be held in person in Tokyo, Japan, from February 17 to 19, 2027.
This PMDA-ATC seminar is organized as an Asia-Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee (RHSC) Training Center of Excellence for Regulatory Science (CoE) workshop. It is expected to provide regulatory officials with practical insights into pharmacovigilance activities, support capacity building among regulatory authorities, and foster regulatory harmonization and cooperation across the Asia-Pacific region.
Key Topics
Participants will gain insights into:
- Overview of pharmacovigilance in Japan
- Development and implementation of Risk Management Plan (RMP)
- Adverse Drug Reaction (ADR) case evaluation
- Identification of safety specifications
- Risk communication using labeling and risk minimization materials
- Utilization of Real-World Data for post-marketing drug safety
Program Components
The seminar includes:
- Expert lectures delivered by APEC regulators, academia, industry representatives
- Case studies and group discussions on ADR case evaluation, identification of safety specifications and development of risk minimization measures
- Participant presentations and experience sharing among regulatory authorities
- Networking opportunities with regulators from across the Asia-Pacific region
Expected Impact
Expected outcomes include:
- Practical insights into pharmacovigilance activities, including ADR case evaluation, safety specification identification, and RMP implementation
- Strengthened regulatory capacity in pharmacovigilance and post-marketing safety management
- Enhanced regulatory harmonization across the Asia-Pacific region through strengthened regulatory capacity, mutual learning, and collaboration among regulatory authorities
Who should apply
Regulatory authority officials ONLY (Begunner to Intermediate level)
- Working in the field of pharmacovigilance with at least three years of practical experience
- English will be the medium at the seminar. Participants should be able to actively participate and engage in lectures and discussions in English.
Priority will be given to applicants from APEC member economies; however, regulators from non-APEC economies are also welcome to apply.
Dates
February 17 - 19, 2027
Program (subject to change)
See the linked program [162KB]
Applications
Apply to participate here: https://www16.webcas.net/form/pub/pmda-atc/pv2027
Complete all required fields and upload the Application Confirmation Form signed by the head of the regulatory authority of your country/region by December 11, 2026, the application deadline. Approximately 30 participants will be selected for in-person participation.
- Participants will be selected by PMDA, from among applicants who submitted required materials. In particular, the Application Confirmation Form must be signed by the head of the the regulatory authority. Applications that do not meet this requirement may not be considered.
- Selected participants will be notified after the application deadline, together with further details regarding the seminar.
- Online participation will be available for select lectures to qualified applicants who are not selected for in person participation. Please indicate if you are interested in virtual participation on the application platform. Please note that the number of online participants may be limited.
Others
Materials will be provided electronically. Participants are recommended to bring their own personal computer to access these materials when needed.
Fee
There is no registration fee for this seminar. Information on travel arrangements and accommodation will be provided to selected for in-person participation.
Further information is available at:http://www.pmda.go.jp/english/int-activities/training-center/0023.html
International travel insurance is not covered by PMDA; PMDA strongly recommends that participants obtain appropriate coverage before departure.
Seminar Location and Format
Tokyo, Japan (In Person) and Online
Inquiries
Secretariat, PMDA Asia Training Center
E-mail: PMDA-ATC[at]pmda.go.jp
Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan
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