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Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the “PMDA-ATC Quality Control (Herbal Medicine) Webinar 2020" for officials from overseas regulatory authorities who are engaged in the review of pharmaceuticals.
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 Webex.
The webinar will cover topics relating to regulation and review process of OTC drugs, Japanese Pharmacopoeia (JP), quality management of herbal medicines. Video about medicinal plant resources and overview of the manufacturer (storage of the raw materials crude drugs) will be shared as well.
The aims of the webinar are to provide chances for the participants to refer back to their work.
The webinar is not open to the industry or non-regulatory authorities.
Participation from many regulatory authorities is welcomed.
Key Webinar Objectives
- To learn basics of regulations for review of herbal medicine including OTC drugs.
- To learn regulatory requirements and quality control of herbal medicine.
- 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 access to “Cisco Webex” and participate in all of the LIVE sessions starting at 2 P.M. Japan Standard Time (JST) during the webinar period via Web browsers. See attached for the system requirements.
- 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 are expected to do self-leaning before LIVE sessions and actively participate in all of the LIVE sessions.
Date / Time
- Pre-LIVE self-learning (viewing videos and e-learning):
September 2 - 7, 2020
- LIVE sessions and Q&A :
September 9, 2020: 2 P.M. – 3:30 P.M. JST (UTC+9)
September 10, 2020: 2 P.M. – 3:30 P.M. JST (UTC+9)
September 11, 2020: 2 P.M. – 3:30 P.M. JST (UTC+9)
Program (subject to change)
See attached for the draft program
Registration (Registration is closed)
Number of participants: approx. 30
Close of registration: August 2, 2020
- Registration request should be made by filling in all the necessary items including signature by the applicant’s supervisor 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 e-mail address shown in “Contact Us” below.
- Early registration is recommended. After the closing date, any change or addition of participant(s) may not be accepted.
- 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, connection test and additional information will be sent to the approved participants after the close of registration.
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.)