Topic 1: The 2nd PMDA Medical Devices Training Seminar begins
Dr. Tatsuya Kondo, Chief Executive of PMDA, gave a welcome speech at the start of the 2nd PMDA Medical Devices Training Seminar, expressing his appreciation to all the participants and emphasized the importance of providing innovative medical products more promptly on global basis. Then greetings respectively from Dr. Toshiyoshi Tominaga, Associate Executive Director, Mr. Kaoru Misawa, International Coordination Officer for Pharmaceuticals and Mr. Teruyoshi Ehara, Office Director of Office of International Programs followed.
Topic 2: Today's lectures
After self introduction of all the participants, Dr. Madoka Murakami of Office of International Programs explained the overall seminar program, then presented the overview of PMDA's role in the Japanese regulatory systems and its active involvement in the international activities, that concluded morning session.
In the afternoon, Mr. Daisuke Koga of Office of International Programs presented the overview of PMD Act, which is the revised version of Pharmaceutical Affairs Law, put into effect on November 25, 2014, clarifying the background of revision and specific measures to promote timely market introduction of innovative products such as regenerative medicine products.
The last lecture of the day was presented by Ms. Naoko Ida and Ms. Yukari Ota of Office of Medical Devices II on Review of Medical Devices and on Review of IVD Reagents, respectively.
There were active Q&A sessions throughout the day, reflecting strong interest of the participants in the Japanese regulations.
Topic 3: Get together party
The get together party was held in the evening. All the participants and many PMDA members including top executives got together and enjoyed friendly conversations. It was a good opportunity to expand cultural relations among the participants.
Comments from participant
 It was a very intense day. The lecturers gave a brief review of the PMDA structure, the Japanese medical device regulations and the review of the medical device dossiers. The lecturers are very experienced. Many questions were raised during Q&A sessions, and the lecturers answered them accurately. The services provided by PMDA were also very considerate; an interpreter was also provided so that there are no language barrier. The seminar is very useful for me.
Mr. Yuanxin (Jack) Liang, Therapeutic Goods Administration (TGA), Australia |
