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Report of the PMDA-ATC MRCT Seminar 2017

PMDA-ATC MRCT Seminar 2017

Pharmaceuticals and Medical Devices Agency (PMDA) recently completed the PMDA-Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (ATC) Multi-Regional Clinical Trial (MRCT) Seminar 2017 on January 23-26, 2017, as a Center of Excellence (CoE) Pilot Workshop for the MRCT/Good Clinical Practice (GCP) Inspection Priority Work Area in the Asia-Pacific Economic Cooperation, Life Sciences Innovation Forum, Regulatory Harmonization Steering Committee (APEC-LSIF-RHSC). This seminar was designed for officials from overseas regulatory agencies who were engaged or interested in the area of MRCT. Total of 32 regulators from 14 economies (Brazil, China, Chinese Taipei, Indonesia, Malaysia, Mexico, Myanmar, Nepal, Papua New Guinea, Peru, Philippines, Sri Lanka, Tanzania and Thailand) joined the seminar.
The seminar opened with remarks by Dr. Junko Sato, Office Director of Office of International Cooperation and Dr. Yoshiaki Uyama, International Senior Training Coordinator as well as Office Director of Office of Medical Informatics and Epidemiology, followed by the keynote speech by Dr. Tatsuya Kondo, Chief Executive of PMDA. Subsequent lectures and the case studies were provided by the staff members from PMDA, as well as those from an overseas regulatory agency, the Japan Pharmaceutical Manufacturers Association (JPMA) and the academic institutions including universities. The seminar consisted of 7 sessions, i.e., MRCT-related basic information, planning and designing, operations, data evaluation, international cooperation and alignment, GCP inspection and post-market safety evaluation (see agenda for details). In each session the participants actively asked questions, which facilitated further understanding. In case studies, in which the participants actively engaged in discussions not only with the facilitators but also within the participants.
In total, more than 49 trainers, including more than 16 staff members from PMDA, contributed to the lectures and case studies.
At the end of the seminar, the course completion certificates were awarded to each participant by Mr. Haruo Akagawa, Director of PMDA-ATC.

Photos and participant comments

MRCT Seminar 2017-01  MRCT Seminar 2017-02


Comments from participants:
"I never knew this point is critical. Therefore from presentation I was able to understand the importance of ethnicity of participants prior to trial participation/initiation. It should be serious considered in conducting the clinical trials."
"I learned about the importance of regulatory harmonization and cooperation. Something that is critical due to global diversities/regional diversities. Also I learned on formal ICH procedures 1-5 and their guideline. Factor/groups that enhance good collaboration among agencies towards achieving harmonization for efficient drug development and for making safety measures based on collected data."
"It is useful to know how an IRB is set up in Japan, as well as the adjustment they have to make to conduct MRCT."

<Case studies>
MRCT Seminar 2017-03  MRCT Seminar 2017-04

Comments from participants:
"The case is interesting. I really appreciate the chance of communication with regulators from other countries. Regulatory frameworks are quite different across countries, so everyone's consideration is different (and may be different from the PMDA's considerations.)"
"Learned issues and solution on MRCT regulator point of views: e.g.; -all countries should collaborate ;-Having common communication system for sharing ideas & issues arise like A in case if the trial is being conducted in other countries; Sponsor to consider ethical concern (e.g. religion of each country. I also learned the pros and cons of joining the Pre-New drug application together with necessary environmental change to increase MRCT in our countries."
"Very interesting case discussion! (probably the best so far)"

<PMDA Tour>
PMDA Tour was conducted to let the participants know and feel an actual atmosphere of scientific consultations and daily activities in PMDA.
MRCT Seminar 2017-05

<Group photo>

MRCT Seminar 2017-06

Overall comments from the participants

Comments from participants:
"The seminar was successful especially in terms of its content which covers the phases of drug development for the MRCT. The importance/challenges of MRCT was well explained. This would be very beneficial for me and my organization for the consideration of MRCT."
"Excellent; with good presenters and the lecturers were very interactive; not exhaustive at all. I have benefit from it a lot in terms of gaining new knowledge."
"This training is much better than I think because PMDA provided a lot of case study, which good to have a discussion."

PMDA-ATC Seminars are held periodically, with a different theme for each seminar.
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, PMDA-ATC@pmda.go.jp

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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