PMDA-ATC Pharmacovigilance Webinar 2023

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Introduction

The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the “PMDA-ATC  Pharmacovigilance Webinar 2023" for officials from overseas regulatory authorities 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) and  will be held on Cisco Systems’ Webex program.
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 Risk and Benefit Balance, Labeling, Pharmacovigilance of COVID-19 vaccine, Risk management plan, Pharmacoepidemiology, Utilization of Real World Data (RWD), etc. 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 participant’s 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 the representatives form academia and 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

1. By participating in this workshop based on the core curriculum endorsed by APEC-LSIF-RHSC, the participants will learn the following knowledge;
   • The evaluation of risk and benefit balance and the assessment of risk minimization activities.
   • Points to consider in developing and implementing the Risk Management Plan (RMP).
   • Analysis and assessment of Adverse Events for efficient and effective pharmacovigilance activities.
2. To utilize the knowledge learned from the webinar to enhance the regulatory system in the participant’s own organization.

Who should apply

Regulators ONLY (Beginner to Intermediate level)

• 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. Prelimiary session

     ‐for internet access confirmation and a brief explanation about the webiner as well as for a team building of the  group like self-introduction,etc. to be held on Monday, January 30.

  2. All of the LIVE sessions

     ‐starting at 2:00 P.M. Japan Standard Time (JST) during the webinar period of February 6 - 8.

Other Points to Note

• The training will be provided in English (with consecutive translation in some sessions).
• All participants should take the PMDA-ATC E-learning Course  (Pharmacovigilance)  (about 133 minutes in total) before attending the live sessions.
• All sessions will be conducted using the Cisco Webex Meeting system.
• Please confirm the attached system requirements.

Date / Time

<Preliminary session>

• January 30 (Mon), 2023   2:00 P.M. -3:00 P.M. JST  (UTC+9)

<LIVE Webinar>

• February 6 (Mon), 2023    2:00 P.M. – 5:20 P.M. JST  (UTC+9)
• February 7 (Tue), 2023    2:00 P.M. – 4:40 P.M. JST  (UTC+9)
• February 8 (Wed), 2023    2:00 P.M. – 4:40 P.M. JST  (UTC+9)
• February 9 (Thu), 2023    2:00 P.M. – 5:50 P.M. JST  (UTC+9)

Program (subject to change)

See the program (attached)

Application (Registration closed)

Number of participants: approx. 30
Close of registration: December 5, 2022
In order to attend the webinar, please be sure to submit both of the following applications.

1. PMDA-ATC Pharmacovigilance Webinar 2023
   • To attend 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/pv2023
   • Confirmation of the registration and additional information on the webinar will be sent to the approved participants after closing the application.
2. PMDA-ATC E-learning Course (Pharmacovigilance)
   • If you have not teken the e-learning course, please use the following link to apply and receive your ID/password. Application webpage: https://www12.webcas.net/form/pub/pmda-atc/e-learning02
     *All participants are required to complete the e-learning course before attending the webinar.
   • Early submission is recommended. After the closing date, any change or addition of participant(s) may not be accepted.
   • If the number of applications for the webinar exceed the upper limit of 30, PMDA, at its discretion, will select the participants based on the information provided in the application form. The applicants who have completed the PMDA-ATC E-learning Course (Pharmacovigilance) may have higher priority in the selection.
   • Confirmation of the registration and additional information will be sent to the approved participants after the close of application.

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●pmda.go.jp
Office of International Program
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan

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