Topic One: The 5th PMDA Training Seminar starts
The 5th PMDA Training Seminar started on Monday October 6th, chaired by Mr. Kaoru Misawa, International Coordination Officer for Pharmaceuticals.
Followed by the Chief Executive, Dr. Tatsuya Kondo's opening remark, Mr. Teruyoshi Ehara, Director of the Office of International Programs, expressed his welcome for all participants and PMDA�fs expectation that this seminar will provide fruitful opportunities and give quality time to all participants.
The participants also had the "Conversation Hour" to introduce themselves each other to talk about their backgrounds, current work areas and their motivation for the seminar. Then Associate Executive Director for International Programs, Dr. Toshiyoshi Tominaga, gave a motivational speech to the participants to facilitate their networking activities. Such kind of program made them closer for the very first day of the seminar.
Topic Two: Today's lectures
The lecturers gave presentation about Overview of PMDA, Pharmaceutical Affairs Act in Japan, Review of Pharmaceuticals, GCP, GMP, Japanese Pharmacopoeia and Drug Master File System, as basic information on Japanese pharmaceutical regulatory system. The participants listened attentively to what the lecturers said, and asked many questions.
Topic Three: Get together party
The get together party was held in the evening. The participants and many PMDA staff members including lecturers and senior officers were gathered and had exciting time. It was a good occasion to expand cultural relations through communication in friendly atmosphere.
Comments from participants:
 Yvonne Siew Khoon Khoo,National Pharmaceutical Control Bureau, Ministry of Health Malaysia In the opening session of the 5th PMDA Training Seminar, the participants were warmly greeted by PMDA's management team led by Chief Executive Dr. Tatsuya Kondo. This was a welcoming relief from the harsh weather in Tokyo. The training coordinators presented an excellent course outline while the participants had opportunity to mention training expectations, all of which were duly noted by the trainers. Subsequent lectures on the Pharmaceutical Affairs Act, pharmaceutical review process, GCP/GMP expectations, and the Japanese Pharmacopeia/Drug Master File system reflected the genuine efforts of PMDA staff to share their experience. As a special mention, the welcoming party at end of Day 1 offered a great opportunity to mingle among participants and PMDA staff. Take home message - Day 1 : No regulatory agency is alone in facing the common regulatory challenges and building camaraderie among regulators will lighten everyone's burden. |
