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[First Announcement] PMDA-ATC Multi-Regional Clinical Trials Seminar 2018

August 16, 2017
Pharmaceuticals and Medical Devices Agency
 

Pharmaceuticals and Medical Devices Agency (PMDA) of Japan is pleased to announce its training program, the “PMDA-ATC Multi-Regional Clinical Trials (MRCT) Seminar 2018”. This seminar, designed for new drug application reviewers from overseas regulatory authorities, will be offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) at PMDA Office in Tokyo from January 15-18, 2018.

As changes from the previous program, PMDA plans to add new sessions which are Hospital Tour and Introduction of review systems and regulations by participants in the program for this fiscal year.
 

Date

January 15 to 18, 2018
 

Venue

Pharmaceuticals and Medical Devices Agency (PMDA)
Shin-kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan
 

Seminar Organized By:

PMDA-ATC
 

This seminar is held as a workshop of the Asia-Pacific Economic Cooperation, Life Sciences Innovation Forum, Regulatory Harmonization Steering Committee (APEC-LSIF-RHSC) Centers of Excellence.
 

Program

  • History of drug evaluation using overseas data
  • Scientific insights about ethnic factors
  • International cooperation and alignment
  • Points to consider when planning and designing MRCT
  • Considerations for MRCT operations
  • Points to consider when evaluating results
  • GCP inspection of global study
  • Post-market safety evaluation of approved drugs based on MRCT
  • Introduction of review systems and regulations by participants (NEW!)
  • Hospital Tour (NEW!)

Registration

Registration for the seminar will be opened around late September.
 

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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