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PMDA-ATC Quality Control (Herbal Medicine) Seminar 2019

Introduction

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.

Key Seminar Objective

  1. To learn basics of regulations for review of herbal medicine including OTC drugs.
  2. To learn the current regulatory requirement and quality control of herbal medicine
  3. 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

  • Officials from overseas regulatory authorities who are currently engaged in the review of pharmaceuticals.
  • 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

December 10 - 12, 2019

Program (subject to change)

See attached for the draft program

Registration (Registration is closed)

Close of registration: September 30, 2019

  • Registration request should be made by filling in all the necessary items including signature by Head of Organization on the application form (attached).  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 will close on September 30, 2019.
  • Early registration is recommended. After the close of registration, we are not able to accept change or addition of participant(s) in principle. 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. Selection of the participants will take place at the discretion of PMDA based on the information provided in the application form.
  • 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

< 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

  • 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.)

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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