The APEC-LSIF-RHSC MRCT/GCP inspection Workshop

Announcement of the APEC-LSIF-RHSC MRCT/GCP inspection Workshop

Pharmaceuticals and Medical Device Agency (PMDA) is pleased to announce the holding of the "APEC-LSIF-RHSC Multi-Regional Clinical Trial (MRCT)/GCP inspection Workshop".
Japan is leading the MRCT/GCP inspection PWA (Multi-Regional Clinical Trial / Good Clinical Practice Inspection Priority Work Area) in the APEC-LSIF-RHSC (Asia-Pacific Economic Cooperation, Life Science Innovation Forum, Regulatory Harmonization Steering Committee) with Thailand as champion economy.

In this PWA, Duke-NUS Medical School and Peking University have been conducting trainings as a pilot Workshop with an aim to be certified as APEC Training Centers of Excellence (CoE) for Regulatory Science. PMDA-ATC (PMDA Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs) is also conducting PMDA-ATC MRCT Seminar 2017 in January 23-26, 2017 as a pilot CoE Workshop for the same purpose.
PMDA is holding the MRCT/GCP Inspection Workshop in conjunction with the completion of the PMDA-ATC MRCT Seminar 2017, to summarize the three CoE pilot workshops held by Duke-NUS Medical School, Peking University, and PMDA, and to discuss the revision of core curriculum and the future direction of the MRCT/GCP CoE curriculums.

Representatives from other experienced regulatory authorities and Japanese/International industry representatives will also make presentations, leading to discuss the revision of core curriculum and future direction in this PWA.
Through discussions in this Workshop, we aim to promote diffusion of the ICH guidelines in the APEC regions.

We welcome participants from the industry, academia, press, etc.
 

Date

January 26, 2017 (Thursday)  13:30 - 17:30 (tentative)

Venue

The Hall at Zen-Nittsu Kasumigaseki building
   Address: Zen-Nittsu Kasumigaseki Building 8F
                  3-3-3, Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, JAPAN
   TEL: +81-3-3581-2261     FAX: +81-3-3592-2776
 

Host

Pharmaceuticals and Medical Devices Agency (PMDA)
Ministry of Health, Labour and Welfare (MHLW)
 

Registration

Please send an e-mail to PMDA-MRCT-WS@pmda.go.jp with your name, title, affiliation, phone and address by January 20, 2017 (Friday), 5:00 p.m. JST
Participation is free of charge.
 
If the request for participation exceeds the capacity of the hall, then we may need to turn the requests down even before the registration deadline.
 

Program

Please see attached, for the details of the program.
 
  Contact：
    Pharmaceuticals and Medical Devices Agency
    Office of International Cooperation
      Phone:  03-3506-9456
      Fax:      03-3506-9572
      E-mail:  PMDA-MRCT-WS@pmda.go.jp