Click here to see the Promotion Flyer [803KB]
Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the “PMDA-ATC Pharmacovigilance Seminar 2025” for officials of new drug application reviewers from overseas regulatory authorities. This seminar will be held IN PERSON, from February 26 to 28, 2025.
The seminar aims to provide chances for the participants to refer back to their work and to find any additional opportunity for enhancement of the pharmacovigilance regulatory system in the post-marketing phase. The seminar will be led not only by PMDA staff members from pharmacovigilance area but also the representatives from academia and the pharmaceutical industry in Japan, allowing participants to think and discuss from multiple perspectives on pharmacovigilance. A lecturer from U.S.FDA will also share about recent pharmacovigilance activities in the US, which will give an international perspective to your knowledge.
Key Objectives of this Seminar
- By participating in this seminar, the participants will learn the following knowledge;
- Evaluation of cases of adverse drug reaction
- Identification of safety specifications
- development and implementation of the RMP
- labeling system and electronic labeling initiatives
- To utilize the knowledge learned from the webinar to enhance the regulatory system in the participant’s own organization.
Who should apply
Regulators ONLY (Intermediate level)
- Employees of regulatory authority with working experience in pharmacovigilance field over 3 years.
- English will be used in the lectures and discussions during the seminar. Participants need an ability to readily communicate in English.
- All participants are recommended to take and complete PV classes of the PMDA-ATC E-learning Course prior to attending the live sessions as the pre-requirement.
Date / Time
- February 26 (Wednesday), 2025 : 10:00 to 16:30 JST (UTC+9)
- February 27 (Thursday), 2025 : 9:30 to 16:30 JST (UTC+9)
- February 28 (Friday), 2025 : 9:30 to 17:00 JST (UTC+9)
Program (subject to change)
See the attached program [121KB]
Application (Registration closed)
Number of participants: approx. 30
Close of registration application: November 27, 2024
To apply for the seminar, please make sure to complete all the necessary items on the application form, including the signature by the applicant's head of the organization, before the closing date. Click the link to apply: https://www12.webcas.net/form/pub/pmda-atc/pv2025
- If applications exceed the upper limit of 30, selection of the participants will take place at the discretion of PMDA.
- Confirmation of registration and additional information will be sent to the approved participants after the closing date.
Others
- Materials will be provided electronically. Participants are recommended to bring their own personal computer to access these materials when needed.
Fee
- Information on travel and hotel reservation assistance will be announced to the approved participants.
- International travel insurance is not covered by PMDA, but PMDA strongly recommends participants to consider obtaining it on your own.
Seminar Location
Tokyo, Japan
Contact Us
For more information, please contact:
Secretariat, PMDA Asia Training Center
E-mail: PMDA-ATC[at]pmda.go.jp
Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
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