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