Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the "PMDA-ATC Pharmacovigilance Seminar 2018" for regulatory authority officials who are engaged in pharmacovigilance activities. The seminar will be offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) at the PMDA Office in Tokyo, on February 5-8, 2018.
The Seminar is held as a workshop of Asia-Pacific Economic Cooperation, Life Sciences Innovation Forum, Regulatory Harmonization Steering Committee (APEC-LSIF-RHSC) Centers of Excellence; however, the Seminar is open to non-APEC economies as well.
The Seminar will cover wide range of topics on pharmacovigilance, including internationally recognized regulations, risk management, global safety data collection and labeling. Small group discussions among participants focusing on risk management plan are planned as well.
The aims of the Seminar are 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 participants’ economies for pharmacovigilance in the post-marketing phase. The Seminar will be led not only by PMDA staff members from pharmacovigilance area but also by representatives from US FDA, academia and the pharmaceutical industry, allowing participants to think and discuss from multiple perspectives on pharmacovigilance.
The seminar is not open to the industry or non-regulatory authorities.
Participation from many regulatory authorities is welcomed.
Key Seminar Objective
By participating in this workshop, the participants should be able to:- Describe regulatory changes to ensure compliance with new pharmacovigilance, risk management, and adverse event reporting initiatives from organizations such as EMA, FDA, PMDA and WHO.
- Review the risk management plan containing pharmacovigilance plan and risk minimization activities for important safety specifications.
- Review the way of risk communication for the risk minimization activities, including its tools (e.g., package insert) and delivery methods.
- Review the pharmacovigilance plan based on the methods to conduct studies and surveillances.
Who should apply
- Employees of regulatory authority with working experience in pharmaceutical field over 3 years including at least 1 year in pharmacovigilance.
- The training will be provided in English (with consecutive translation in some sessions).
- All participants are expected to actively participate in all of the sessions.
Date / Time
February 5-8, 2018
Program (subject to change)
See attached the draft program
Registration (Registration is closed.)
- Registration request should be made by filling in all the necessary items on the application form and sending it by e-mail to the e-mail address shown in “Contact Us” below.
- Registration will close on November 10, 2017.
- Early registration is recommended. The registration may close before the deadline depending on the number of application. Also, please be sure to allow enough time to obtain the visa for entry to Japan.
- If the number of applications exceeds the capacity, the number of participants from each country may be limited.
- Confirmation of the registration and additional information will be sent to the approved participants after the close of registration.
Fee
There is no registration fee for this seminar.
Information on travel and hotel reservation assistance will be announced to the approved participants.
Location
Pharmaceuticals and Medical Devices Agency (PMDA):
Shin-kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan
Access
Please use public transportation. Nearest Tokyo Metro Subway Stations:
- 5 minutes' walk from Exit 11 of Toranomon Station on the Ginza Line
- 8 minutes' walk from Exit 3 of Kokkai-gijido-mae Station, on the Marunouchi Line, Chiyoda Line
- 8 minutes' walk from Exit A13 of Kasumigaseki Station, on the Marunouchi Line, Chiyoda Line, Hibiya Line
- 10 minutes' walk from Exit 8 of Tameike-sanno Station, on the Ginza Line, Nanboku Line
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.)