Topic One: The final day of the 5th PMDA Training Seminar
On Day 5, Post-marketing Safety Measures for Pharmaceuticals and Relief Services were lectured. Those are significantly important components for the PMDA mission, so-called "Safety-triangle". The participants asked many questions to understand the missions of PMDA in addition to the review function.
Topic Two: Wrap up of the Training Seminar
After the whole sessions of the seminar, Dr. Tominaga delivered closing remark that this seminar would expand the capacity of the participants for wider collaboration among the regulatory authorities including PMDA. Finally, each participant received the certificate for successful completion of the 5th training seminar from Mr. Misawa.
PMDA intends to hold the training seminar on a continuous basis. We look forward to your participation in our next seminar.
Comments from participants:
 Ali Mohammed AlsamilSaudi FDA, Saudi Arabia First of all, the training seminar covered all aspects regarding the regulation of drug. I have learned a lot from the Japanese experience and the national contribution of MHLW. The contribution is a good example of how to master the regulation system in the developed countries. Secondly, I have noticed that focusing on Safety and Efficacy Studies. However, is it possible to devote future seminar for Quality Review as well. Finally, I hope there will be a training seminar for only biological product "Safety, Efficacy and Quality". On behalf of the biological Evaluation directorate at Sfda, we are with honorary participating or of our assessor to the future training seminar at Pmda. |
 Laila Mouawad, Francis Reisdorfer, and Raquel Silva ANVISA, Brazil This training was a very good and comprehensive seminar about the drug and medical device registration system in Japan. We had the great opportunity to know something about PMDA flowchart and compare to other agencies' ones. It was good because we could discuss about current affairs as biosimilars and tissue and cellular products. It was also a food opportunity to share much information and experience with PMDA and other important agencies. In the name of ANVISA drugs and biological products super intendancy, we'd like to thank PMDA team for excellent explanations. |
