Topic One: Lectures of the Third day morning
On Day 3, Clinical Trials and Consultation and Cross-sectional Projects were lectured to participants in the morning session. PMDA has progressed the improvement of review process in both quantitative and qualitative aspects, and those presentations explained how PMDA works so hard for this issue.
Topic Two: Lunch time seminar
During the lunch time, one of the participant, Dr. Li Fung Peck from Singapore HSA had a presentation to introduce the outline of her organization and the current hot topic for Singapore regulators in the global context. There were 30 audiences, and Q&A session was also fruitful.
Topic Three: Group work 1 (Pharmacokinetics in Drug Development)
In the afternoon, the staffs from the Office of New Drug Review I and IV had the group work, in which the participants were divided into three groups to discuss the case studies prepared by the PMDA staffs. Two case studies regarding pharmacokinetics in drug development were given. The participant had exciting discussion and demonstrated their views at the wrap up session, and took group photo with the group work coordinators.
Comments from participants:
 Hsiao Yun ChenCenter for Drug Evaluation, Taiwan It's a very good opportunity for us to know more about the PMDA drug review system. The whole training program was well organized and very helpful. By way of group work(question discussion), we learned the content of ICH E5 and CTD M5.3.1-5.3.4. We also understand why dose the property make likely to be sensitive to ethnic factors. The PMDA staffs who organized this training seminar were very responsible and prepared very well. It's a very successful training seminar. |
