Click here to see the Promotion Flyer [505KB]
Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the “PMDA-ATC Pharmaceuticals Review Webinar 2024" for officials from overseas regulatory authorities who are engaged in the review of pharmaceuticals.
The webinar will be provided by on-line live session from December 10 to 12, 2024.The webinar will cover topics relating to regulations on CMC review of generic drug, review of drugs using Drug Delivery System, Bioequivalence (BE) study, review of biosimilars and generic drugs, etc. Group discussion among participants on case study is planned as well.
Key Webinar Objectives
- To learn the key regulations of the review of pharmaceuticals in Japan.
- To learn review point of generic drugs, biosimilar drugs, OTC drugs and quasi drugs.
- To learn Bioequivalence (BE) guideline and BE study.
- To obtain an opportunity to discuss how to review generic drugs.
Who should apply
Regulators ONLY (Beginner to Intermediate level)
- Regulatory officials or relevant agencies/institutes employees with at least 3 years of experience in generic drugs or other pharmaceuticals review.
- English will be used in the lectures and discussions during the webinar. Participants need an ability to readily communicate in English.
Date / Time
- December 10 (Tuesday), 2024: 14:00 to 17:00 JST (UTC+9)
- December 11 (Wednesday), 2024: 14:00 to 17:30 JST (UTC+9)
- December 12 (Thursday), 2024: 14:00 to 17:15 JST (UTC+9)
Program (subject to change)
See the attached program [65KB]
Application (Registration closed)
Number of participants: approx. 35
Close of application: October 15, 2024
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/pharm2024
- If applications exceed the upper limit of 35, 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
All sessions will be conducted using the Cisco Webex Meeting system.
Please confirm the attached system requirements [151KB]
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
Office of 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
(Note: For the purpose of security, @ in the e-mail addresses are replaced with [at]. Please replace [at] with @ when you send an e-mail.)