On January 20-23, Pharmaceuticals and Medical Devices Agency (PMDA) completed the PMDA-Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (ATC) Multi-Regional Clinical Trial (MRCT) seminar 2020. This seminar was designed for new drug application reviewers from overseas regulatory agencies who were engaged in the area of MRCT, was held 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 27 regulators from Bangladesh, Brazil, Chile, Hong Kong, India, Indonesia, Malaysia, Peru, Philippines, Russia, Saudi Arabia, Sri Lanka, Taiwan, and Thailand joined the seminar.
The seminar opened with remarks by Dr. Yoshikazu Hayashi, Senior Executive Director of PMDA and Director of PMDA-ATC, as well as the welcome speech by Dr. Yasuhiro Fujiwara, Chief Executive. Subsequent lectures and case studies were provided by staff members from PMDA, Japan Pharmaceutical Manufacturers Association and academic institutions. This seminar consisted of 7 sessions, i.e., information sharing of review systems and regulations by participants, international cooperation and alignment, planning and designing, data evaluation, operations, regulatory review based on results of GCP inspections, and post-market safety evaluation (see agenda for details). On Day 3, clinical trial site tour to National Cancer Center Hospital (Tokyo) was conducted. In each session, participants listened lectures diligently and involved in Q&A in a proactive manner. Besides, all participants addressed group work actively and were able to deepen their understanding through the case studies. In the case studies, discussions not only among participants but also with facilitators were underway.
In total, around 40 trainers including 17 staff members from PMDA, contributed to the lectures and facilitation of case studies.
At the end of the seminar, the course completion certificate was handed to each participant by Dr. Yoshikazu Hayashi.
Comments from participants:
“The speaker is an expert in the subject matter and was able to answer all the queries. Points discussed were informative in a way that these can be used or adapted by other countries for effective implementation.”
“The example help me to understand ICH E17 G/L, especially, process of identify in ethnic factors. In part of 1st endpoint, I agree with him that it should be relevant to target population.”
“Presentation contents were very informative that can be adopted by different region for implementation.”
“The presentation included the real case studies of PMDA & a lot of insight were provided on how results were interpreted and how decisions were made.”
Comments from participants:
“Very good interaction between participants from different countries. Good learning opportunity through discussion. Good feedback from facilitators”
“It is very good case because this is the real case that happens when we evaluate the result of clinical data.”
“Good strategy to stimulate our thought on the way to improve regulatory system and to promote MRCT. “
“The case studies were interesting, it involved lot of discussions with participants including the discussions regarding GCP inspection in their countries, the pros & cons of their systems, Japan (PMDA) approval, and listed out the answers to the questions provided at the end of case study.”
“I am very much glad and honored to attend this type of seminar from PMDA. The contents of this seminar regarding global view is very helpful for my country to make decisions specially in case of GCP inspection, Risk Management System and post-marketing surveillance activities and drug development process. ”
“It was an amazing experience for me because the themes in discussion are very important for the regulators in my country. The content of the seminar was very helpful to me and the country. The speakers are very good. The staff also is amazing.”
“The seminar is well organized and truly satisfactory. The presenters were all experts in the concern field, and shared their knowledge to the participants. Case studies were the real highlight for the seminar. These case studies involved deep discussion among participants which involved the knowledge sharing among all the participating countries.”
“This seminar was very organized seminar. In our country, clinical trials regulatory division is started recently. These days, we are developing guidelines (on evaluating clinical trials, contents of clinical trials, GCP inspections, etc.). So, this was very helpful to us. We got a chance to share knowledge among other countries / regions. Seminar contents are very good.”
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 (e-mail: PMDA-ATC●pmda.go.jp).
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