PMDA-ATC with National Cancer Center MRCT 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 with National Cancer Center MRCT Webinar 2022" for officials from new drug application reviewers from overseas regulatory authorities. The webinar is offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC), with the collaboration of the Clinical Research Support Office of the National Cancer Center Japan (NCC), and will be held on Cisco Webex in order to support for establishment and maintenance of clinical trial sites in Asian region.  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 seminar aims to promote drug development and convergence of regulations by sharing accumulated experiences of Japan, such as protocol designing and planning of MRCT, clinical data evaluation, clinical operation. The seminar will be led not only by PMDA reviewers and NCC experts but also by representatives from academia and industry, allowing participants to think and discuss from multiple perspectives.

The webinar is not open to the industry or non-regulatory authorities. Participation from many regulatory authorities is welcomed.  In addition, a few clinical investigators recommended by NCC will also join.

Key Webinar Objectives

1. To learn the current situation surrounding MRCTs (e.g. under COVID-19 pandemic)
2. To obtain an opportunity to discuss how to make regulatory decisions based on specific cases
3. To build a skilled human capacity in regulatory science to promote and facilitate MRCTs
4. To enhance the regulatory and clinical cooperation in the APEC region on the evaluation
   and regulation of MRCTs

Who Should Apply

• Senior clinical reviewers with at least 3 years of hands-on experience in the assessment of
  clinical trial applications, benefit-risk profiles for market approvals.

• 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 11.
  2. All of the LIVE sessions starting at 2 P.M. Japan Standard Time (JST) during the webinar
     period of January 18 - 21.
• 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 should take and complete the PMDA-ATC MRCT E-learning course before
  LIVE sessions and actively  participate in all of the LIVE sessions.

Date / Time

• Preliminary Session

    January 11, 2022   2:00 P.M. - 3:00 P.M. JST (UTC+9)

• LIVE Lectures and Case Studies

    January 18, 2022    2:00 P.M. - 4:20 P.M. JST (UTC+9)
    January 19, 2022    2:00 P.M. - 5:00 P.M. JST (UTC+9)
    January 20, 2022    2:00 P.M. - 5:00 P.M. JST (UTC+9)
    January 21, 2022    2:00 P.M. - 4:45 P.M. JST (UTC+9)

Program (subject to change)

See attached program

Application (Registration is closed)

• Number of participants: approx. 30
• Closing date : November 28, 2021 (Extended)
• To attend the webinar, please make sure to complete both of the following applications.

1) PMDA-ATC MRCT E-learning Course
    If you haven't applied for the E-learning course, please access the following link
    and receive your ID/PW.   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/mrct2022

• Early registration 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.
• 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 seminar.
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.)