Topic One: Case-Study Discussion
On the fourth day, participants divided into three groups to discuss the cases of post-marketing safety measures based on Adverse Drug Reaction (ADR) Reports, etc. in Japan.
In the group work, PMDA staff members of its Office of Safety II explained the reviewing process in PMDA and the Japanese system on safety measures to deepen understanding among participants.
Topic Two: Report the cases from participants
In the afternoon session, the cases in each country were reported by participants.
This session was quite a meaningful opportunity to exchange the information among participating agencies.
Topic Three: Presentation by the participant from National Agency of Drug and Food Control (NADFC)
After the program DAY4, the participants from National Agency of Drug and Food Control (NADFC), Republic of Indonesia made a presentation on the outline of NADFC and its regulatory system of pharmaceutical affairs.
The questions and answers were lively exchanged to enhance the attendees’ better understanding today again.
Comments from participants
It is our great honor to be invited to attend this training seminar which has provided us with useful insight on the systems and processes of PMDA. The PMDA staffs have been exceedingly helpful and friendly, and we truly appreciate their assistance. We had a great stay in Tokyo and enjoyed our time in this beautiful city. Ms. Na Lim, Ms. Sin Yun Cheah, Ms. Wong Khai Peng, Ms. Ho Swee Jiuan and Ms. Agnes Jia Ying Goh, Health Sciences Authority (HSA), Singapore |
ASAHIKAWA, Hokkaido |
