Click here to see the Promotion Flyer[259KB]
Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the “PMDA-ATC Pharmacovigilance Webinar 2024” for officials from overseas regulatory authorities who are engaged in pharmacovigilance activities. This webinar will be held virtually from February 26 to 29, 2024.
This webinar is held as the workshop of Asia-Pacific Economic Cooperation, Regulatory Harmonization Steering Committee (APEC-RHSC) Center of Excellence, however, the webinar is open to non-APEC economies as well.
The webinar aims to provide chances for the participants to refer back to their work and to find any additional opportunity for enhancement of the regulatory system in participant’s economies for pharmacovigilance in the post-marketing phase. The webinar 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 representative from U.S.FDA will have a special session about pharmacovigilance activities in the US. In this time, we renew whole contents of group works from the previous seminar. Participants will work about ADR case evaluation, identification of safety specification and development of risk management plan.
Key Objectives of this Webinar
- By participating in this workshop based on the core curriculum endorsed by APEC-RHSC, the participants will learn the following knowledge;
- The evaluation of risk and benefit balance and the assessment of risk minimization activities.
- Points to consider in developing and implementing the Risk Management Plan (RMP).
- How labeling system and electronic labeling work and update of labeling.
- To utilize the knowledge learned from the webinar to enhance the regulatory system in the participant’s own organization.
Who should apply
Regulators ONLY (Beginner to Intermediate level)
- Employees of regulatory authority with working experience in pharmaceutical field over 3 years including at least 1 year in pharmacovigilance.
- English will be used in the lectures and discussions during the webinar. Participants need an ability to readily communicate in English.
- All participants are encouraged to take and complete the PMDA-ATC E-learning Course of “Pharmacovigilance” prior to attending the live sessions as the pre-requirement.
Date / Time
- Feburary 26 (Monday), 2024 : 14:00 to 17:10 JST (UTC+9)
- Feburary 27 (Tuesday), 2024 : 14:00 to 17:00 JST (UTC+9)
- Feburary 28 (Wednesday), 2024 : 14:00 to 17:00 JST (UTC+9)
- Feburary 29 (Thursday), 2024 : 14:00 to 17:20 JST (UTC+9)
Program (subject to change)
See the attached program[152KB]
Application (Registration closed)
Number of participants: approx. 30
Close of registration: December 25, 2023
In order to attend the webinar, please be sure to submit both of the following applications.
To apply for the webinar, please make sure to complete all the necessary items on the application form, including the signature by the applicant's supervisor, before the closing date.
Click the link to apply: https://www12.webcas.net/form/pub/pmda-atc/pv2024
- If applications exceed the upper limit of 30, selection of the participants will take place at the discretion of PMDA. Participants will be selected from the person who have completed the PMDA-ATC Pharmacovigilance E-learning Course on a priority basis.Click the link to apply: https://www12.webcas.net/form/pub/pmda-atc/e-learning02
- Confirmation of registration and additional information will be sent to the approved participants after the closing date.
Others
All sessions will be conducted using the Cisco Webex Meeting system.
Please confirm the attached system requirements.
Fee
There is no registration fee for this webinar. Any expenses incurred with participation in the webinar will not be covered by PMDA.
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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