Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the "PMDA-ATC Multi-Regional Clinical Trial (MRCT) Seminar 2017" 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 PMDA Office in Tokyo, from January 23 - 26, 2017.
The Seminar is held as APEC-LSIF-RHSC's APEC Center of Excellence Pilot Workshop; however, the Seminar is open to non-APEC economies as well.*
With the increase in global product development and the ICH E17 guideline (General principle on planning/designing Multi-Regional Clinical Trials) close to being harmonized, product reviews based on multi-regional clinical trials driven data are also increasing. Under this situation, it is essential that regulators adequately evaluate the benefit-risk balance while keeping in mind the ethnic factors.
The Seminar aims to promote drug development and convergence of regulations by sharing accumulated experiences of Japan, such as product development, product review, GCP inspections, safety measures, etc. The Seminar will be led not only by PMDA reviewers but also by representatives from academia and industry, allowing participants to think and discuss from multiple perspectives.
The seminar is not open to the industry or non-regulatory authorities.
Participation from many regulatory authorities is welcomed.
*APEC-LSIF-RHSC: Asia-Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum (LSIF) Regulatory Harmonization Steering Committee (RHSC)
Key Seminar Objectives
- Build skilled human capacity in regulatory science to promote and facilitate Multi-Regional Clinical Trials (MRCTs)
- Enhance regulatory cooperation in the APEC region on the evaluation and regulation of MRCTs
Who should apply
- Senior clinical reviewers with at least 3 years of hands-on experience in the assessment of clinical trial applications, benefit-risk profiles for market approvals and post-market activities
- Trainings are provided in English (simultaneous Japanese–English translation in some sessions)
- All participants are expected to actively participate in all of the sessions.
Date / Time
January 23 to 26, 2017.
Program Outline (subject to change)
Click here for the details of the program (version as of November 18, 2016)
DAY 1 (January 23, 2017)
- Opening
- Keynote speech
- Trends of drug evaluation utilizing clinical data from other countries/regions
- Protocol designing and planning of MRCT
DAY 2 (January 24, 2017)
- Operational considerations
- Clinical data analysis
DAY 3 (January 25, 2017)
- Importance of international cooperation and regulatory convergence among regulatory authorities
- GCP findings in the review of MRCT
DAY 4 (January 26, 2017)
- Pharmacovigilance in clinical trials and post-market setting
Registration
- Registration request should be made by filling in all the necessary items on the application form and sending it by e-mail to PMDA-ATC@pmda.go.jp
- Registration will close on November 30, 2016. 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
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