Topic 1: Today's lecture
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To start the final day of the seminar, Ms. Mio Yagi of Office of Non-clinical and Clinical Compliance gave a presentation on the Inspections of Application Dossiers for Medical Devices, focusing on how to handle clinical and non-clinical data. Then, Dr. I Kaku of Office of Medical Devices II presented Clinical Trial for Medical Devices explaining the situations where clinical trials are required and various points to consider as well as necessary regulatory procedures in conducting clinical trials. |
In the afternoon session, Dr. Seiko Usami and Dr. Miho Sato of Office of Safety I presented on Post-Marketing Safety Measures for Medical Devices in Japan. The comprehensive post-marketing vigilance system, including adverse event reporting and registries for medical devices, was introduced. Various information were also shared in the Q&A session.
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Topic 2: Wrap-up and Presentation of Certificates
Dr. Toshiyoshi Tominaga, Associate Executive Director, gave closing remarks to conclude the seminar, emphasizing the importance of network and urged the participants to take full advantage of the tie developed during the seminar. After the closing remarks, the certificates of completing the seminar were presented to each participant. PMDA appreciated the eagerness and diligence displayed by all the participants.
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Comments from participant
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I really enjoyed the seminar and it gave me a new perspective on FDA; influence on other regulatory agencies. Bringing different nations together like this was excellent. I hope more Americans get this experience. Mr. Andrew Durfor, FDA, U.S.A. |
