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PMDA-ATC Quality Control (Herbal Medicine) 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 Quality Control (Herbal Medicine) Webinar 2021" for officials from overseas regulatory authorities who are engaged in the review of pharmaceuticals.
The webinar is offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) by using the Cisco Webex Meeting system.

The webinar will cover topics relating to regulations on herbal medicines and quality management of herbal medicines, by live lectures and an interactive case-study session. Video about medicinal plant resources and overview of the manufacturer (storage of the raw materials of crude drugs) will be shared as well.
The webinar is not open to the industry or non-regulatory authorities. Participation from many regulatory authorities is welcomed.

Key Webinar Objectives

  1. To learn the basics of regulations for review of herbal medicine including OTC drugs.
  2. To learn regulatory requirements and quality control for herbal medicine.
  3. To make use of the learnings and reflect it back to the regulatory system in the participant's organization.

Who should apply

  • Attendees who can participate in both of the following time slots.
    1. Preliminary session for internet access testing as well as for self introduction to be held about one week prior to the live session.
    2. All of the LIVE sessions  starting at 2 P.M. Japan Standard Time (JST) during the webinar period.
      All sessions will be conducted using the Cisco Webex Meeting system. For the system requirement details see the Cisco Webex Help Center.
  • 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.
  • Basic knowledge of the regulations pertaining to the herbal product 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 should take the PMDA-ATC Quality Control (Herbal Medicine) E-learning Course (about 120 min in total) prior to attending the live sessions.

Date / Time

< Preliminary Session>
  •  June 15 (Tue), 2021   : 2:00 P.M. – 3:00 P.M. JST (UTC+9)

<Live Webinar>
  • June 22 (Tue), 2021   : 2:00 P.M. – 4:30 P.M. JST (UTC+9)
  • June 23 (Wed), 2021  : 2:00 P.M. – 4:30 P.M. JST (UTC+9)
  • June 24 (Thu), 2021   : 2:00 P.M. – 4:30 P.M. JST (UTC+9)

Program (subject to change)

See attached the program

Application (Registration is closed)

Number of participants: approx. 30
Close of application:  May 16, 2021

  • To attend the webinar, please make sure to complete both of the following applications.

1) PMDA-ATC E-learning Course
If you haven't applied for the e-learning training 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.

  • Early submission is recommended. After the closing date, any change or addition of participant(s) may not be accepted.
  • If applications exceed the upper limit of 30, selection of the participants will take place at the discretion of PMDA.    Participants will be selected from the person on a priority basis who have completed the PMDA-ATC Quality Control (Herbal Medicine) E-learning Course.
  • 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.
However, communication expenses concerning 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

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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