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Pharmaceuticals and Medical Devices Agency (Japan) pmda.go.jp

[IBENTO][IBENTO]PMDA-ATC MRCT/GCP Inspection Seminar 2027 applications open

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Announcement

Applications are now open for regulatory officials

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.

  • Planning and Design of Multi-Regional Clinical Trials (MRCTs), Including Sponsor Perspectives
  • GCP Inspections in Japan and Latest Perspectives on ICH E6(R3)
  • Industry and Clinical-Site Perspectives on GCP Inspections
  • 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
  • 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
  • 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.

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    October 03, 2026 20:39
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