From January 18 to 21, PMDA convened an online seminar entitled "PMDA-ATC with National Cancer Center MRCT Webinar 2021" with the collaboration of the Clinical Research Support Office of the National Cancer Center (NCC) Japan.
This webinar was designed for new drug application reviewers from overseas regulatory agencies involved in the area of MRCT, as the Center of Excellence (CoE) workshop for MRCT and Good Clinical Practice (GCP) under the Asia-Pacific Economic Cooperation, Life Sciences Innovation Forum, Regulatory Harmonization Steering Committee (APEC-LSIF-RHSC). Total of 25 participants including regulators from countries/regions such as Indonesia, Myanmar, Peru, Philippines, Taiwan, Tanzania and Uganda, and clinical investigators from Philippines and Viet Nam joined the webinar.
Recorded lectures and case-study materials were prepared and provided by staff members from PMDA, representatives of the Japan Pharmaceutical Manufacturers Association (JPMA), NCC, the National Center for Global Health and Medicine (NCGM), the National Institute of Health Sciences (NIHS), Kitasato University and Gifu University as the preliminary training materials.
The lectures covered subjects on protocol designing and planning of MRCT, clinical operation, clinical data evaluation, regulatory review based on results of GCP inspections, international cooperation and regulatory convergence among regulatory authorities (see agenda for details).
The webinar opened with remarks by Mr. UZU Shinobu, Senior Executive Director of PMDA and Director of PMDA-ATC, Dr. NAKASHIMA Nobumasa, Senior Executive Director and the incumbent Co-Chair of APEC-LSIF-RHSC, Dr. NAKAGAMA Hitoshi, President of NCC and Dr. NAKAMURA Ryuta, Senior Coordinator for International Training of PMDA. Questions and Answers sessions for the preliminary training followed on the first day, where participants communicated actively with the lecturers.
From the second through the fourth day, the participants were divided into five groups where they engaged in the case studies on three aspects of MRCT – planning & designing, evaluating of the results and considerations for operation. Participants exchanged opinions not only with each other but also with the facilitators from PMDA, JPMA, academia, and deepened their understanding throughout the group works.
The webinar closed with remarks by Dr. FUJIWARA Yasuhiro, Chief Executive of PMDA, Dr. SHIMADA Kazuaki, Director of the NCC Hospital and Dr. SATO Junko, Director of the Office of International Programs, PMDA. The course completion certificates were handed virtually to each participant by Dr. FUJIWARA Yasuhiro.
<Opening & Closing>
Comments from participants:
<Recorded Lectures and Q&A sessions>
"Slide presentations were excellent. Facilitators were very accommodating."
"The live discussions clarified some questions in the video lectures."
"The presentation is very well prepared. The examples incorporated are greatly appreciated as it emphasizes more the key points to be remembered and understood."
"From this Q&A session we can get clear information and gain our knowledge about the points to consider in planning and designing MRCT."
"The provision of an actual sample is highly appreciated as this provided me a better understanding on the key points to be considered in the evaluation of MRCT results."
"This session is informative and an eye-opener on the MRCT operations from investigator's viewpoint."
< Case studies >
"The case study was interactive. The individual ideas were valid."
"I was able to form links and relate well the factors that are key in the design stage as well as those important in the evaluation process."
"It was a very nice session that we can exchange our information about MRCT operation from each country. So we can gain more knowledge about challenges and recent implementation of clinical trial (MRCT) in each country."
"It is a great discussion, we can share from one country to another and also from the facilitator (Japan)."
"It was a nice experience. It builds my new perspective about clinical trial and open a network to MRCT collaboration."
"This seminar has provided me a very good learning opportunities on MRCT. I appreciate that the seminar incorporated information from designing, evaluating and operations of MRCT. This seminar gave me a fresh perspective as a regulator."
"I gained a lot of knowledge on MRCT not just from PMDA perspective, but also from my neighboring countries. I was able to relate on the status of our regulatory system with them. Overall, it was a great training experience."
PMDA-ATC Seminars are held periodically, each with a different theme.
The Seminar announcements are posted on this website.
For any questions regarding PMDA Training Seminar, please contact us by clicking on the “Contact us” logo on top of the website, or please contact the Secretariat (e-mail: PMDA-ATC●pmda.go.jp).
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