The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the “PMDA-ATC Quality Control (Herbal Medicine) Seminar 2019" for officials from overseas regulatory authorities who are engaged in the review of pharmaceuticals.
The Seminar will be offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) at Toyama Prefecture, from December 10-12, 2019.
At the Seminar, overview of PMDA, overview of herbal medicine regulations in Japan, review of OTC drugs, Review and GMP inspection by prefectural authorities, Japanese Pharmacopoeia (JP), approval standards for Kampo products and non-Kampo crude products, quality control and manufacturing control for herbal medicines will be shared. Manufacturing site tour of herbal extract and storage of raw materials are planned as well.
The aims of the Seminar are to provide chances for the participants to refer back to their work and to find any additional opportunity for enhancement of the participant's regulatory system.
The seminar is not open to the industry or non-regulatory authorities.
Participation from many regulatory authorities is welcomed.
December 10 - 12, 2019
See attached for the draft program
Close of registration: September 30, 2019
There is no registration fee for this seminar.
Information on travel and hotel reservation assistance will be announced to the approved participants.
< December 10 >
A seminar room in Toyama
< December 11 >
A seminar room in Toyama city and Prefectural Research Center for Medical Plants in Toyama
< December 12 >
Manufacturing site in Toyama and a seminar room in Toyama city
10 minutes' walk from Toyama Station (South Exit)
For more information, please contact:
Secretariat, PMDA Asia Training Center
Office of International Cooperation
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan
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