From January 18 to 21, 2022, PMDA convened an online seminar entitled “PMDA-ATC with National Cancer Center MRCT Webinar 2022" 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, 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 Innovation Forum, Regulatory Harmonization Steering Committee (APEC-LSIF-RHSC). A total of 39 participants including regulators from economies such as Azerbaijan, China, Chinese Taipei, India, Indonesia, Pakistan, Papua New Guinea, the Philippines, Saudi Arabia and Thailand, and academia clinical research professionals from Hong Kong-China, 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.
The webinar opened with remarks by Mr. UZU Shinobu, Senior Executive Director of PMDA and Director of PMDA-ATC, Dr. NAKASHIMA Nobumasa, Associate Executive Director and the Co-Chair of APEC-LSIF-RHSC, Dr. NAKAGAMA Hitoshi, President of NCC and Dr. NAKAMURA Ryuta, Senior Coordinator for International Training of PMDA.
The LIVE webinar comprised lectures and Q&A on Scientific insights about ethnic factors, Academic Research Organization (ARO) and COVID-19 related projects and 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 participation among participating economies was held. Participants actively engaged in discussion and exchanged opinions, which lead to further and deeper understanding of MRCT.
(see agenda for details).
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 certificate was handed virtually to each participant by Dr. FUJIWARA Yasuhiro.
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Comments from the participants:
“I received valuable explanation regarding the clinical trial conducted in this pandemic situation and to overcome the challenges.”
“Case discussions were very useful and beneficial as we all learnt from each other's experiences.”
“It was a very informative session & I have learned a lot regarding different scenarios across different economies.”
“I've never review any clinical study protocol in my agency. However, because of this case study, I can understand the general principal about the planning and designing MRCT.”
“This session is excellent in terms of execution, mastery of subject, and engaging the needs of the attendees overall.”
“The round table discussion was handled and executed excellently. Ample time was given to present and Q&A portion is quite enjoyable.”