PMDA-ATC with National Cancer Center MRCT Webinar 2021

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Introduction

The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the “PMDA-ATC with National Cancer Center MRCT Webinar 2021" for officials engaging in 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 the 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.

With the increase in global product development, the ICH E17 guideline (General principle for planning and design of Multi-Regional Clinical Trials) has been finalized and its training material has been developed. Product reviews based on multi-regional clinical trials driven data are also increasing. Under this situation, it is essential that regulators adequately evaluate the benefit-risk balance while keeping in mind the ethnic factors.

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, regulatory review based on results of GCP inspections. 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. 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
2. To learn the key regulatory flow of the drug development utilizing MRCTs
3. To obtain an opportunity to discuss how to make regulatory decisions based on specific cases
4. To build a skilled human capacity in regulatory science to promote and facilitate MRCTs
5. To enhance the regulatory and clinical cooperation in the APEC region on the evaluation and regulation of MRCTs
6. To increase the acceptability of MRCT data by multiple regulatory authorities.

Who should apply

• Attendees who can access to “Cisco Webex” and participate in all of the LIVE sessions starting after 1 P.M. for Day 1 and 2 P.M. for Day2-4 Japan Standard Time (JST) during the webinar period via Web browsers.  See attached the system requirements.
• Attendees are also required to do self-learning, prior to the LIVE sessions, using the E-learning System “Platon” provided by LOGOSWARE.Co.,Ltd. (https://pmda-atc.platon.jpn.com).
• 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.

Other Points to Note

• The training will be provided in English (with consecutive translation in some sessions).
• All participants are expected to do self-learning before LIVE sessions and actively participate in all of the LIVE sessions.

Date / Time

• Pre-LIVE self-learning (viewing recorded lectures and related information on e-learning system):

          January 11-15, 2021

• LIVE Lectures and Case Studies:

          January 18, 2021  1:00 P.M. -5:00 P.M. JST (UTC+9)
          January 19, 2021  2:00 P.M. -4:00 P.M. JST (UTC+9)
          January 20, 2021  2:00 P.M. -4:00 P.M. JST (UTC+9)
          January 21, 2021  2:00 P.M. -4:00 P.M. JST (UTC+9)

Program (subject to change)

See attached for the program

Registration  (closed)

Number of participants: approx. 30
Close of registration: November 3, 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.

Each participating agency is responsible for obtaining computer access to Cisco Webex program and LOGOSWARE Platon.

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.)