PMDA-ATC Parmaceuticals Review Seminar 2024 for PPWG member states
The PMDA-ATC Pharmaceuticals Review Seminar 2024 for PPWG member states was conducted from June 11 to June 14. In April this year, the PMDA held the PMDA-ASEAN Reliance Meeting, inviting regulatory authorities of ASEAN member states and WHO. In the discussions at the meeting, it was demonstrated that the technical skills of the regulators of ASEAN, who are engaged in pharmaceutical review, should be enhanced to promote the utilization of Reliance. Considering this, this seminar provided ASEAN regulatory reviewers with a practical case study-based training program to improve their skills in evaluating data on new drugs. A total of 27 people participated from Brunei Darussalam, Cambodia, Indonesia, Laos PDR, Malaysia, Myanmar, Philippines, Thailand, and Vietnam.
The seminar opened with the remarks by Dr. SUZUKI Hiroshi, Executive Director of PMDA.
On the first day, lectures were delivered on an overview of new drug reviews in Japan and points to consider when evaluating new drugs. Subsequently, in the roundtable discussion, participants presented the status and issues of the joint assessment, followed by a discussion with all participants and the WHO (online). On the second day, lectures were delivered on the structure and content of the PMDA review report and risk management plan. A case study of data evaluation, using an application document, was conducted on quality data. On the third day, case studies were conducted to evaluate the toxicological, pharmacological, and pharmacokinetic data. On the fourth day, a case study was conducted to evaluate the clinical data. A total of 19 lecturers and facilitators were appointed from the PMDA.
(see the program for details[115KB])
This event was closed with the remark by Dr. SUZUKI Hiroshi. As a token of active participation in the workshop, the digital certification of Open Badge was given to the participants.
Photos and participant comments
Comments from the participants:
“Well structured and comprehensive.”
“This seminar enabled the participants to learn more about quality, safety, and efficacy evaluation from the experts from the PMDA.”
“Have learned in greater detail how to evaluate clinical and non-clinical data which I will use during evaluation of new drug product”
“The seminar served as a venue for inter-collaboration of ASEAN member states that will hopefully be translated to better cooperation and efficiency in ASEAN joint assessment.”
“The core of the clinical review process will be applied in national and ASEAN joint assessment.”
