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PMDA-ATC Pharmacovigilance Webinar 2022


Click here to see the Promotion Flyer

Introduction

The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the “PMDA-ATC Pharmacovigilance Webinar 2022” for overseas regulatory authority officials who are engaged in pharmacovigilance activities. The webinar will be offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) on Cisco Webex.
The webinar is held as the workshop of Asia-Pacific Economic Cooperation, Life Sciences Innovation Forum, Regulatory Harmonization Steering Committee (APEC-LSIF-RHSC) Center of Excellence; however, the webinar is open to non-APEC economies as well.
The webinar will cover topics on pharmacovigilance such as internationally recognized regulations, global safety data collection and evaluation of risk/benefit balance, labelling, risk management plan including pharmacovigilance and risk minimization activities, as well as pharmacoepidemiology. Group discussions among participants using case studies are planned as well.
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 regulatory system in participants’ economies for pharmacovigilance in the post-marketing phase. 
The webinar will be led by PMDA staff members from pharmacovigilance area and academia, the pharmaceutical industry in Japan. A representative from U.S.FDA will have a special session about pharmacovigilance activities in the US. The program will allow participants to think and discuss from multiple perspectives on pharmacovigilance.
The webinar is not open to the industry or non-regulatory authorities. Participation from many regulatory authorities is welcomed.

Key Webinar Objectives

By participating in this workshop based on the core curriculum endorsed by APEC-LSIF-RHSC, the participants will learn the following knowledge that they could utilize in order to enhance the pharmacovigilance system in the participant’s own organization:

  1. The evaluation of benefit/risk balance and the assessment of risk minimization activities.
  2. The labeling process and electronic labeling.
  3. Points to consider in developing and implementing the Risk Management Plan (RMP),
  4. Analysis and assessment of Adverse Events for efficient and effective pharmacovigilance activities.

Who should apply

  • Employees of regulatory authority with working experience in pharmaceutical field over 3 years including at least 1 year in pharmacovigilance.
  • Attendees who can participate in both of the following time slots.
    1) Preliminary session for internet access confirmation and a brief explanation about the webinar as well as for a team building of the group like self- introduction, etc. to be held on January 25.
    2) All of the LIVE sessions starting at 2 P.M. Japan Standard Time (JST) during the webinar period of January 31 and February 2 - 4. *No live session on February 1.
  • All sessions will be conducted using the Cisco Webex Meeting system. Please confirm the attached system requirements.

Other Points to Note

  • The training will be provided in English (with consecutive translation in some sessions).
  • All participants are required to take the PMDA-ATC Pharmacovigilance E-learning Course (takes about 130 minutes in total) before attending the live sessions.

Date / Time

  • Preliminary Session
    January 25, 2022 2:00 P.M. -3:00 P.M. JST (UTC+9)
  • LIVE Lectures and Case Studies January 31, 2022 2:00 P.M. -4:10 P.M. JST (UTC+9)
    February 2, 2022 2:00 P.M. -4:10 P.M. JST (UTC+9)
    February 3, 2022 2:00 P.M. -4:10 P.M. JST (UTC+9)
    February 4, 2022 2:00 P.M. -4:30 P.M. JST (UTC+9)
          *No live session on February 1.

Program (subject to change)

See attached program

Application (Registration closed)

  • Number of participants: approx. 30
  • Closing date : November 30, 2021
  • To attend the webinar, please make sure to complete both of the following applications.

1) Pharmacovigilance E-learning Course

If you have not applied for PMD-ATC Pharmacovigilance E-learning course, please access the following link and receive your ID/password. Click the link to apply:
https://www12.webcas.net/form/pub/pmda-atc/e-learning01
*All participants are required to complete the E-learning course before attending the webinar.

2) Live Webinar

Please fill in all the necessary items on the application form, including the signature by the applicant's supervisor by the closing date. Click the link to apply:
https://www12.webcas.net/form/pub/pmda-atc/pv2022

  • Early application is recommended. After the close of application, we are not able to accept change or addition of participant(s) in principle.
  • If the number of applications exceeds the maximum number of participants allowed, participants will be selected at the discretion of PMDA.
  • Confirmation of the registration and additional information will be sent to the approved participants after the close of application.

Fee

There is no application fee for this webinar. However, communication expenses concening the participation in the webinar will not be borne by PMDA.

Contact Us

For more information, please contact: Secretariat, PMDA Asia Training Center
 E-mail: PMDA-ATC●pmda.go.jp

Division of Training Center Management   
Office of International Programs
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan
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JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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