Pharmaceuticals and Medical Devices Agency (PMDA) completed the PMDA-Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (ATC) Pharmaceuticals Review Seminar 2017 in Bangkok, Thailand on December 12-15, 2017. This seminar was designed for new drug application reviewers from overseas regulatory agencies. Total of 20 regulators from Sri Lanka (2) and Thailand (18) joined the seminar.
The seminar opened with remarks by Dr. Junko Sato, Office Director, Office of International Cooperation, followed by lectures and group works provided by PMDA staff members. The topics discussed included outline of PMDA, activities from clinical trial application to approval, the relief services for sufferers from adverse drug reactions, toxicology, Good Clinical Practice (GCP)/Good Laboratory Practice (GLP) inspections, product reviews for new drugs and generic drugs, post-marketing safety measures, Risk Management Plan (RMP), and recent challenge to accelerate drug development in Japan. In addition, group discussions were actively conducted for the case study on the product review. The participants actively engaged in discussions throughout the seminar and made presentations on the regulations of their regulatory authorities (see agenda for details).
In total, 11 staff members from PMDA contributed to the lectures and case studies.
On the final day of the seminar, the Course completion certificates were handed to each participant by Dr. Junko Sato.
Lectures were provided by experts of product review, relief services and drug safety. There were also presentations by representatives from Sri Lanka and Thailand about their own pharmaceuticals review systems and regulations. Participants enthusiastically asked many questions and all the lecturers answered those questions.
Comments from the participants:
“I have read review report from PMDA and was wondering about how ADR report in clinical trials covered or how the evaluation is going. Now pretty clear on the issue about the process.”
“In part of Toxicology, it’s very important to follow the patient or physician after the use of the medicine. And this is the important for study the part of Toxicology because it’s made me aware for suitable dose before we formulate and launch chemical to medicine and various use in citizens.”
“The reliable document is really important and relevant with the Good Clinical Practice that you lecture to me; like medical institutions document-based inspections (CRF check, DM check and statistical analysis). The all of document has contained by necessary knowledge.”
“Risk communication in drugs after launch to the market should be followed. It’s very important in our team like health officer (Pharmacists and Doctors) Thank you for sharing your policy and process in this topic.”
“The presentation provide a good detail of SAKIGAKE system and the special measures to support the R&D in Japan.”
Group discussion in the case study session was one of the key sessions of the seminar. The case study provided opportunities where the participants discussed with other regulators as well as PMDA staff members on the important points to be kept in mind while conducting the product review.
Comments from the participants:
“Your hint is – show me how to use the limited information for interpret as the indications, precautions, warning and the point of concern for further monitoring about the risk-benefit.”
“It’s a good opportunity to practice and work together with participants. The same as to know each other because our interaction to solve or find out basic cases that challenge us. Thank you for your workshop. “
“This is the greatest case study that give me very clear guidance to apply on my current job.”
“Excellent. Very informative and useful. As regulatory officers I personally feel that we should more improved using the global regulatory procedures.”
“All information in this seminar make me to know overview of PMDA tasks that is important to use for public health surveillance.”
“The seminar gave me the systemic thinking process, time management & enlighten me how to use all information effectively (especially Day 3 workshop).”
“The topic covers all the areas that is needed for regulatory science.”
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).
Note: For the purpose of security, @ in the e-mail address is replaced with ●. Please replace ● with @ when you send an e-mail.