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4th PMDA Training Seminar(DAY 4)

Topic One: Case study

On Day 4, participants were divided into three groups and discussed about 3 cases on changes in manufacturing scale, method and in assay of drug product.

Case studyCase study

In the group work, staff members of the Office of OTC/Generic Drugs introduced PMDA's review policy on the necessity of application regarding minor changes.

 

Topic Two: Report the cases from participants

In the last session, cases in several countries were reported by the participants. The valuable information was provided to deepen understanding of the situations in other countries.

Report the cases from participantsReport the cases from participantsReport the cases from participants
 

Comments from participants

Ms. Lusiana Puspita Sari and Ms. Wenny Trias Ramadanty, National Agency of Drug and Food Control (NADFC) Republic of Indonesia

Joining this training is a good opportunity for us to know about drug registration system in Japan. At this time, we can also exchange information of drug evaluation among overseas participants. This training has also informative topics with deep discussion. Hopefully, the information can be used as a references for our registration system improvement.

Ms. Lusiana Puspita Sari and Ms. Wenny Trias Ramadanty, National Agency of Drug and Food Control (NADFC) Republic of Indonesia


 
Japanese View 4

Kirigamine heights, Tochigi

 

< DAY 3 DAY 5 >

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Chiyoda-ku, Tokyo 100-0013 Japan

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