PMDA-ATC with National Cancer Center (NCC) MRCT Seminar 2024
The PMDA held the “PMDA-ATC with National Cancer Center (NCC) MRCT Seminar 2024” in collaboration with the NCC Hospital Japan from January 23 to 26. This seminar served as the Center of Excellence (CoE) workshop for the Multi‐Regional Clinical Trials (MRCT) and Good Clinical Practice (GCP) inspection, designated by the Asia Pacific Economic Cooperation, Regulatory Harmonization Steering Committee (APEC‐RHSC). This seminar was intended for officials of overseas regulatory agencies and clinical research investigators. It was attended by 27 participants, mostly regulators from Chinese Taipei, Egypt, Hong Kong, Indonesia, Malaysia, Pakistan, the Philippines, Saudi Arabia, Sri Lanka, Thailand, and Vietnam.
The seminar opened with the remarks by Dr. FUJIWARA Yasuhiro, Chief Executive of PMDA, followed by Dr. NAKAGAMA Hitoshi, President of National Cancer Center.
On the first day, lectures on scientific insights about ethnic factors and consideration for MRCT operation were provided. During the round table discussion, representatives presented on MRCT operations in each country/region, and active discussions followed. The second day included a lecture and a case study on “points to consider when planning and designing MRCT,” while the third day covered “points to consider when evaluating MRCT results.” The participants were divided into groups and had intensive discussion in each case study. On the final day, lectures on the development of the Asian Clinical Trial Network were provided. Throughout this seminar, in addition to PMDA and NCC staff members, lecturers and facilitators from the National Institute of Health Science (NIHS), Japan Pharmaceutical Manufacturers Association (JPMA), National Center for Global Health and Medicine (NCGM), and several industries also shared their expert knowledge and comments with participants, which contributed to this meaningful seminar. (See the program for details[363.95KB])
This event was closed with the speech from Dr. UZU Shinobu, Senior Executive Director of PMDA, and Director of the Asia Training Center for PMDA, followed by the speech from Dr. SHIMADA Kazuaki, Director of the National Cancer Center Hospital. Dr. NAKAMURA Ryuta, Office Director - Office of New Drug I and Senior coordinator of the Seminar attended both the opening and the closing session. As a token of active participation in the seminar, the digital certification of Open Badge was given to the participants.
Photos and participant comments
"It was a very informative seminar with opportunity to learn from experts."
"Overall, the course arrangement is great and not compact. Thanks for the arrangement."
"Very useful, provide new information, The organizers are very friendly and supportive"
"As always it was a wonderful opportunity to learn about MRCTs and to know other regulatory bodies' perspectives."
"More examples and case studies on actual problematic designs and issues encountered by PMDA during regulatory technical review and what was the resolution."
"For my future work, I will make some revision on standard operating procedure to include MRCT (protocol and evaluating result of MRCT)."
