Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the “PMDA-ATC Quality Control (Herbal Medicine) Seminar 2018" 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 October 22-24, 2018.
At the Seminar, the details of regulatory activities for herbal medicine including quality control and manufacturing control will be shared. Manufacturing site tour and practice of dissolution test 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.
Key Seminar Objective
- To learn basics of regulations and regulatory organization
- To learn the current regulatory requirement and quality control of herbal medicine
- To make use of the learnings/ findings from discussions and reflect it back to the regulatory system in the participant's organization.
Who should apply
- Pharmaceuticals reviewers from regulatory authorities.
- A basic knowledge of the regulations pertaining to the herbal product review in his/her organization is required.
- The training will be provided in English (with consecutive translation in some sessions).
- All participants are expected to actively participate in all of the sessions.
- A participant from each country/ region should present his/her regulatory requirement in his/her country/region to other participants.
Duration
October 22 -24, 2018
Program (subject to change)
See attached for the draft program
Registration (Registration is closed)
- Registration request should be made by filling in all the necessary items including signature by Head of Organization on the application form. Please send the form in both the Word file (without signature) and the PDF file (with signature) by e-mail to the e-mail address shown in “Contact Us” below.
- Registration was closed on August 12, 2018.
- Early registration is recommended. The registration may close before the deadline depending on the number of applications. Also, please be sure to allow enough time to obtain the visa for entry to Japan.
- If the number of applications exceeds the capacity, the number of participants from each country may be limited.
- Confirmation of the registration and additional information will be sent to the approved participants after the close of registration.
Fee
There is no registration fee for this seminar.
Information on travel and hotel reservation assistance will be announced to the approved participants.
Location
< October 22-23 >
- Toyama Prefectural Civic Center (Kenmin Kaikan)
4-18 Shinsokawa, Toyama-shi, Toyama 930-0006, JAPAN
TEL: +81-(0)76-432-3111
< October 24 >
- A manufacturer’s site
- Toyama Prefectural Institute for Pharmaceutical Research
17 Chome-1 Nakataikoyama, Imizu, Toyama Prefecture 939-0363 JAPAN
Access
- Toyama Prefectural Civic Center (Kenmin Kaikan)
10 minutes' walk from Toyama Station (South Exit)
Contact Us
For more information, please contact:
Secretariat, PMDA Asia Training Center
E-mail: PMDA-ATC●pmda.go.jp
Office of International Cooperation
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan
(Note: For the purpose of security, @ in the e-mail addresses are replaced with ●. Please replace ● with @ when you send an e-mail.)