Topic One: Lectures of the Forth day morning
On Day 4, Cellular and Tissue-based Products and Biosmiliar were lectured to participants in the morning session. In Japan, regulatory framework of cellular and tissue-base products is getting changed with the amendment of Pharmaceutical Affairs Act and other new acts related to regenerative medicine. The participants aggressively asked to the lecturers about new regulatory system in Japan to catch up such advanced challenge.
Topic Two: Lunch time seminar
During the lunch time, one of the participant, Shanti Marlina Sibuea from Indonesia NADFC had a presentation to introduce the outline of her organization and the future direction of international strategy for Indonesian regulators.
Topic Three: Group work 2
In the afternoon, the staffs of the Office of New Drug Review I had the Group Work 2 "Learn about the review of anti-diabetic drug". The group members were kept in the same as the ones on Day 3 to make sure their own progress of group work activities. The program was consisted of two sets of Mini lecture, Small group work, and Presentation/Discussion sequence. Themes included the review of the efficacy and the safety of the anti-diabetes drug, multi-regional clinical trial and the guidance for industry.
Comments from participants:
 Hyungok ChunMinistry of Food and Drug Safety, Korea I am from Korea MFDS. Korea and Japan is neighboring countries. But nowadays, Korea Pharmaceutical Regulatory Authority doesn't know the Japan's pharmaceutical system. So, this is the very good case of understating Japan's system. Especially, the group discussion were very helpful to understand NDA Review system of Japan. For saving time, there were two seminars of participants in lunch time. It also helped understating other countries' system. My suggestions follows. 1. For more application, would you give or send pdf file of seminar material? 2. For next participants, early notification of theme will be helpful. Thanks. |
