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Events and Symposia

PMDA-ATC with National Cancer Center MRCT Webinar 2023

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Introduction

The Pharmaceuticals and Medical Devices Agency (PMDA) of Japan is pleased to announce the "PMDA-ATC with National Cancer Center MRCT Webinar 2023" for officials of 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 virtually using Cisco's WebEx program 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 webinar aims to promote drug development and convergence of regulations by sharing accumulated experiences of Japan, such as protocol designing and planning of MRCT, clinical operation and clinical data evaluation, and discussing clinical trial networking beyond the COVID-19 pandemic with participants from around the world. It 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.A few clinical investigators recommended by NCC will also join.Participation from many regulatory authorities is welcomed.

Key Webinar Objectives

  1. To learn the current situation surrounding MRCTs (e.g. under/beyond 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

Regulators ONLY (Intermediate level)

  • 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. Prelimiary 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 10, 2023.
    2. All of the LIVE sessions  starting at 2:00 P.M. Japan Standard Time (JST) during the webinar period of January 16  – 19, 2023.
      All sessions will be conducted using the Cisco Webex Meeting system.Please confirm the attached system requirements.
  • The training will be provided in English (with  English-Japanease consecutive translation in some sessions).
  • All participants should take and complete the PMDA-ATC E-learning Course prior to attending the live sessions as the pre-requirement.

Date / Time

<Preliminary session>

January 10 (Tue), 2023   2:00 P.M. - 3:00 P.M. JST  (UTC+9)

<LIVE Webinar>

January 16 (Mon), 2023    2:00 P.M. - 4:30 P.M. JST  (UTC+9)
January 17 (Tue), 2023    2:00 P.M. - 5:15 P.M. JST  (UTC+9)
January 18 (Wed), 2023    2:00 P.M. - 5:15 P.M. JST  (UTC+9)
January 19 (Thu), 2023    2:00 P.M. - 4:55 P.M. JST  (UTC+9)
                                                                    (ending time varies)

Program (subject to change)

See the program (attached)

Application   (Registration closed)

Number of participants: approx. 30
Close of registration: November 28, 2023
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 get your ID/Password.
    Application webpage: https://www12.webcas.net/form/pub/pmda-atc/e-learning02
    *All applicants 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 before the closing date.
    Click the link to apply: http://www12.webcas.net/form/pub/pmda-atc/mrct2023

  • 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.  Participants who completed the PMDA-ATC MRCT E-learning Course will be given priority.
  • Confirmation of the registration and additional information will be sent to the approved participants after the closing date.

Fee

  • There is no registration fee for this seminar. 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

Division of Training Center Management
Office of International Program
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.)