Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the "PMDA-ATC Pharmaceuticals Review Seminar 2018" for pharmaceuticals reviewers from overseas regulatory authorities.
The Seminar will be offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) in Tokyo and Toyama prefecture, from June 18-22, 2018.
The Seminar will cover a wide range of topics including product review for not only new drugs but also generic drugs and biosimilars, CMC, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), etc. through the lecture and case study, aiming to provide the participants with opportunities to acquire knowledge and perspectives to enhance the regulatory system in the participants' own country or region.
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 key regulatory flow of the product development to post-approval
The Seminar will focus on the following key regulatory activities.
- Consultations (Scientific Advice)
- Product review
- To make use of the learnings from case studies and 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 pharmaceutical product review in his/her organization is required.
- The training will be provided in English (with simultaneous translation in some sessions).
- All participants are expected to actively participate in all of the sessions.
Duration
June 18 to 22, 2018. See attached program for draft schedule.
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 (attached). Please send the form in both the Word file (without signature) and the PDF file (with signature) by e-mail to PMDA-ATC●pmda.go.jp
- Registration was closed on April 6, 2018.
- Early registration is recommended. The registration may close before the deadline depending on the number of application. 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 meeting 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
Pharmaceuticals and Medical Devices Agency (PMDA):
Shin-kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan
Please note that the venue of the first day is NOT PMDA office and details will be informed in due course.
Access
Please use public transportation. Nearest Tokyo Metro Subway Stations:
- 5 minutes' walk from Exit 11 of Toranomon Station on the Ginza Line
- 8 minutes' walk from Exit 3 of Kokkai-gijido-mae Station, on the Marunouchi Line, Chiyoda Line
- 8 minutes' walk from Exit A13 of Kasumigaseki Station, on the Marunouchi Line, Chiyoda Line, Hibiya Line
- 10 minutes' walk from Exit 8 of Tameike-sanno Station, on the Ginza Line, Nanboku Line
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.)