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1st PMDA Medical Devices Training Seminar(DAY 1)

Topic 1: The 1st PMDA Medical Devices Training Seminar starts

The 1st PMDA Medical Devices Training Seminar starts

The commemorable1st PMDA Medical Devices Training Seminar has just started today with the opening remarks from Dr. Tatsuya Kondo, Chief Executive of PMDA. Dr. Kondo pointed out that in recent years, medicines and medical devices have made remarkable advance and needs are growing for prompt and universal provision of more effective and safe products to our society on a global basis. He also stressed the importance of regulatory science which was originated from Japan and has been the basis of the review of medical devices, which is the subject of this seminar.

After Dr. Kondo's speech, Ms. Tomiko Tawaragi, Associate Executive Director, offered her greetings.


Topic 2: Today's lectures

Today's lectures

Firstly, the overview of PMDA activities was presented followed by introduction of MHLW and the Japanese regulations for medical devices to conclude the morning session. In the afternoon, the overview of medical devices review and consultation was presented, while regulatory science and review of in vitro diagnostics were explained, respectively. Today's session was concluded with the presentation on health and medical services in Japan and PMDA's international activities. The participants are very attentive and all the lecturers received extensive questions.


Topic 3: Get together party

Get together party Get together party

The get together party was held in the evening. All the participants and many PMDA staff members got together and enjoyed the food and drink, including some ethnic delicacies such as satay and samsa, as well as frank conversations. It was a good opportunity to expand cultural relations through communications in a friendly atmosphere.


Comments from participants

Officers from Taiwan, Dr. Luk, Ms. Wu, Dr. Yeh and Ms. Ku (from left to right) We appreciated the hospitability and efforts made by PMDA organizing committee. We believe that today's lectures have fulfilled the following goals and merits to the audience:
  1. Clearly discriminated the roles and functions between PMDA and MHLW,
  2. Well explained current Japanese laws and regulations regarding the medical devices review and processes,
  3. Responded and answered all the questions from the floor.

The audiences are looking forward to the following lectures in the next four days.

Officers from Taiwan, Dr. Luk, Ms. Wu, Dr. Yeh and Ms. Ku (from left to right)

Japanese View 1




DAY 2 >

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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