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PMDA-ATC Pharmacovigilance Webinar 2021


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 2021” 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 a 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 wide range of topics on pharmacovigilance, including internationally recognized regulations, global safety data collection and evaluation of accumulated safety data, risk management based on the risk management plan including pharmacovigilance plan and risk minimization action plan including risk communication like labeling per safety specification. 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 not only by PMDA staff members from pharmacovigilance area but also by representatives from U.S.FDA, academia and the pharmaceutical industry, allowing 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:

 
  • The importance of harmonized regulatory strategy in ICH guideline and regulatory updates to ensure compliance with new pharmacovigilance, risk management, and adverse event reporting, etc.,
  • The risk management tools and benefit-risk analysis for pharmacovigilance and risk minimization action per safety specifications identified by signal detection and benefit-risk analysis,
  • The importance of collection and accumulation of adverse drug reaction reports and methodology of signal detection using such accumulated data, from the point of view of pharmacoepidemiology, and
  • The risk communication with stakeholders utilizing labeling and periodic reports such as Periodic Benefit Risk Evaluation Report (PBRER).

Who should apply

  • Attendees who can access to “Cisco Webex” and participate in all of the LIVE sessions starting from 2 p.m. JST each day, throughout 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 authority with working experience in pharmaceutical field over 3 years including at least 1 year in pharmacovigilance.

Other Points to Note

  • The training will be provided in English (with consecutive translation in some sessions).
  • All participants are expected to do self-learning before LIVE sessions and actively participate in all of the LIVE sessions.

Date / Time

  • Pre-LIVE self-learning (viewing videos and e-learning) :

          January 21-29, 2021

  • LIVE Lectures and Q&A

          February 1, 2021 2:00 P.M. -4:40 P.M. JST (UTC+9)
          February 2, 2021 2:00 P.M. -4:30 P.M. JST (UTC+9)
          February 3, 2021 2:00 P.M. -4:30 P.M. JST (UTC+9)
          February 4, 2021 2:00 P.M. -4:50 P.M. JST (UTC+9)

Program (subject to change)

See attached for the program

Registration

Number of participants: approx. 30
Close of registration: December 2, 2020

  • Registration request should be made by filling in all the necessary items including signature by Head of Organization on the application form (attached). Please send the form in both the Word file (without signature) and the PDF file (with signature) by e-mail to the sending address shown in “Contact Us” below.
  • Early registration is recommended. After the close of registration, we are not able to accept change or addition of participant(s) in principle. 
  • If there are more applications, 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 and additional information will be sent to the approved participants after the close of registration.

Fee

There is no registration fee for this webinar.

Each participating agency is responsible for obtaining computer access to Cisco Webex program and LOGOSWARE Platon.

Contact Us

For more information, please contact:

Secretariat, PMDA Asia Training Center
E-mail: PMDA-ATC●pmda.go.jp

Office of International Programs
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.)

JCN 3010005007409

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

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