Here begins the text.
PMDA-ATC Pharmaceuticals Review Webinar 2020
Click here to see the Promotion Flyer
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the “PMDA-ATC Pharmaceuticals Review Webinar 2020" for officials from overseas regulatory authorities who are engaged in the review of pharmaceuticals.
The webinar will be offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) and will be held on Web, from December 15-17, 2020.
The webinar will cover topics relating to product review for new drugs, generic drugs and biosimilars, and efficient review pathways for early access as well, through Q&A sessions and case studies to promote comprehensive understanding of the regulatory systems.
The aims of the webinar are to provide chances for the participants to refer back to their work and to find any additional opportunity for enhancement of the participants’ regulatory systems.
The webinar is not open to the industry or non-regulatory authorities.
Participation from many regulatory authorities is welcomed.
Key Webinar Objectives
- To learn the key regulatory flow of the product development
The webinar will focus on the following key regulatory activities.
- Regulatory process from clinical trial to approval
- Review of new drugs
- Review of generic drugs and biosimilars
- Innovative review pathways
- To make use of the learnings from case studies and discussions and reflect it back to the regulation in the participant's organization.
Who should apply
- Attendees who can access to “Cisco Webex” and participate in all of the LIVE sessions starting at 1:00 p.m. Japan Standard Time (JST) during the webinar period via Web browsers. See attached the system requirements.
- Attendees are also required to do self-learning, prior to the LIVE sessions, using the E-learning System “Platon” provided by LOGOSWARE.Co.,Ltd. (https://pmda-atc.platon.jpn.com).
- Employees of regulatory authorities, or other agencies/institutes closely related thereto. Officials from overseas regulatory authorities who are currently engaged in the review of pharmaceuticals.
- Pharmaceutical reviewer with at least 3 years of experience in the review of pharmaceuticals.
- Basic knowledge of the regulations pertaining to the pharmaceuticals review in his/her organization is required.
Other Points to Note
- The training will be provided in English (with consecutive translation in some sessions)
- All participants are requested to do self-leaning before the LIVE sessions and actively participate in all of the LIVE sessions.
Date / Time
- Pre-LIVE self-learning (viewing videos on e-learning system):
December 7-11, 2020
- LIVE Q&A and Case Studies:
December 15, 2020 13:00 – 17:20 JST (UTC+9)
December 16, 2020 13:00 – 16:10 JST (UTC+9)
December 17, 2020 13:00 – 16:20 JST (UTC+9)
Program (subject to change)
See attached for the draft program
Number of participants: approx. 30
Close of registration: October 19, 2020
- Registration requests should be made by filling in all the necessary items including the signature of the applicant’s supervisor on the application form (attached).Please send the form as a Word file (without signature) and a PDF file (with signature) by e-mail to the e-mail address shown in “Contact Us” below.
- Early registration is recommended. After the closing date, any change or addition of participant(s) may not be accepted.
- If there are more applications than available spaces, selection of the participants will take place at the discretion of PMDA based on the information provided in the application form.
- Confirmation of the registration, connection test and additional information will be sent to the accepted participants after the close of registration.
There is no registration fee for this webinar.
Each participating agency is responsible for obtaining computer access to Cisco Webex program and LOGOSWARE Platon.
For more information, please contact:
Secretariat, PMDA Asia Training Center
Office of International Program
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.)