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Report of the PMDA-ATC with National Cancer Center MRCT Webinar 2023

PMDA-ATC with National Cancer Center MRCT Webinar 2023

From January 16 to 19, 2023, PMDA convened an online seminar entitled “PMDA-ATC with National Cancer Center MRCT Webinar 2023" in collaboration with the Department of International Clinical Development of the National Cancer Center (NCC) Hospital Japan.

This webinar, focusing on multi-regional clinical trials, was designed for new drug application reviewers from overseas regulatory agencies and clinical research investigators, as the Center of Excellence (CoE) workshop for MRCT and GCP inspection Priority Work Area, which is led by Japan with Thailand as champion economies in the Asia-Pacific Economic Cooperation, Life Sciences Innovations Forum, Regulatory Harmonization Steering Committee (APEC-LSIF-RHSC). A total of 27 participants including regulators from economies such as Azerbaijan, Chile, Chinese Taipei, India, Indonesia, Malaysia, Pakistan, the Philippines, Peru, Saudi Arabia, Sri Lanka, Thailand, and clinical research professionals from Malaysia, Singapore and Thailand took part.

Before attending the LIVE webinar, participants took the PMDA-ATC E-learning course, “Multi-Regional Clinical Trial (MRCT) “covering the following subjects; How to conduct GCP inspection, Points to consider when planning & designing MRCT and when evaluating MRCT results, and Trial Conduct amidst the COVID-19 Pandemic, etc.

The webinar opened with remarks by Mr. UZU Shinobu, Senior Executive Director of PMDA and Dr. NAKAGAMA Hitoshi, President of NCC.   Subsequent lectures were provided by the staff member of PMDA, National Cancer Center Hospital, Japan Pharmaceutical Manufacturers Association (JPMA) and several academic institutions and industry.  The LIVE webinar comprised lectures and Q&A on Scientific insights about ethnic factors, Development of Asian Clinical Trial Network, in addition to Case Studies on Points to consider when planning and designing MRCT (Day 2) and when evaluating MRCT results (Day 3). On the final day of the webinar, a round table discussion on the benefits and challenges of MRCT among participating economies was held. Participants actively engaged in discussion and exchanged opinions, which lead to participants’ further and deeper understanding of MRCT.
 (see agenda for details).

The webinar closed with remarks by Dr. SHIMADA Kazuaki, Director of the NCC Hospital, and Dr. FUJIWARA Yasuhiro, Chief Executive of PMDA. The course completion certificate was virtually given to each participant by Dr. FUJIWARA.

Photos and participant comments


<Opening & Closing>


Comments from the participants:
“It was an excellent opportunity to learn about MRCT. I wish to be part of the training of PMDA in future also.”
“Very interesting session of Q/A and to understand more of E17 and the point of view of different economies for application.”
“The lecture stressed the needs and importance of knowing the ethnic factors that affects the results of trials”
“Interesting change of opinions, and then the point of view of PMDA”
“I got new perspective of using digital technology full in conducting clinical trial.”
“I really appreciate if PMDA also provide on-site training so we can focus just on the material and conduct to try GCP inspection on-site.”