Topic One: Lectures of the second day morning
Day 2 program was exciting for the participants since various topics of new drug reviews were delivered in one day. The program started with a lecture on Quality Standards (chemicals and biopharmaceuticals). Following those classes, Toxicology were lectured in the morning session. The participants listened fascinatingly all the time despite of the hard schedule, and had variety of questions to lecturers.
Topic Two: Lectures of the second day afternoon
In the afternoon, Pharmacology, Pharmacokinetics, Clinical Data, Cardiovascular Risk and Biostatistics were lectured. Whole topics were so useful for the participants to deepen their understanding of how to evaluate the safety and efficacy of new drug in Japan, which was also good preparedness for the group work from Day 3.
Comments from participants:
 Boontarika BoonyapiwatMinistry of Public Health, Thailand The activities on second day contain in-depth knowledge needed for all reviewers. The topics are well prioritized and this makes the trainees to understand easily. The training materials for each topic are easy to follow. The training on quality standards of both chemicals and biopharmaceuticals make me understand how PMDA reviews the dossier and this can be directly adapted for my work. Other training topics including toxicology, pharmacology, pharmacokinetics, clinical data, cardiovascular risk and bio-statistics also helps to broaden my view. The overall activities are very effective and interesting. |
