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Applications are now open for regulatory officials
Seminar Overview
The APEC CoE Workshop: PMDA-ATC MRCT/GCP Inspection Seminar 2027 is a training program for regulatory officials. It will be held in person in Tokyo, Japan, from January 26 to 29, 2027.
This PMDA-ATC seminar, organized as an Asia-Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee (RHSC) Training Center of Excellence for Regulatory Science (CoE) workshop, is expected to provide regulatory officials with practical insights into MRCT review and GCP inspection practices, support capacity building among regulatory authorities, and foster regulatory harmonization and cooperation across the Asia-Pacific region.
Key Topics
Participants will gain insights into:
- Planning and Design of Multi-Regional Clinical Trials (MRCTs), Including Sponsor Perspectives
- Evaluation of MRCT Results
- AI-Assisted Clinical Trial Operations
- Clinical Trial Networks in Asia
- GCP Inspections in Japan and Latest Perspectives on ICH E6(R3)
- Industry and Clinical-Site Perspectives on GCP Inspections
Program Components
The seminar includes:
- Expert lectures delivered by regulators, industry representatives, and clinical-site professionals
- Case studies and group discussions on GCP inspections and MRCT evaluation
- 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 MRCT review and GCP inspection practices
- Strengthened regulatory capacity in the oversight of clinical trials and GCP inspections
- 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 (Intermediate level)
- Clinical trial reviewers or GCP inspectors 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
January 26 - 29, 2027
Program (subject to change)
See the linked program [136KB]
Applications
Apply to participate here: https://www16.webcas.net/form/pub/pmda-atc/mrctgcp2027
Complete all required fields and upload the Application Confirmation Form signed by the head of the regulatory authority of your country/region by October 27, 2026, the application deadline. Approximately 30 participants will be selected.
- Participants will be selected by PMDA, from applicants with required materials submitted in accordance with instructions.In particular, the Application Confirmation Form must be signed by the head of 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.
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 participants.
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)
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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