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Report of the PMDA-ATC Pharmaceuticals Review Seminar 2016

PMDA-ATC Pharmaceuticals Review Seminar 2016

Pharmaceuticals and Medical Devices Agency (PMDA) recently completed the PMDA-ATC Pharmaceuticals Review Seminar 2016, the very first seminar after the launch of PMDA Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) on July 25-29, 2016. This seminar was designed for officials of regulatory agencies overseas engaged in drug reviews. Total of 13 regulators from 7 regulatory agencies (i.e. China, Hong Kong, Indonesia, Korea, Malaysia, Taiwan, and Thailand) have joined the seminar.
The seminar opened with welcome speeches by Dr. Tatsuya Kondo, Chief Executive and Mr. Haruo Akagawa, the Director of Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs, followed by lectures and group works from the staff members at PMDA.
In the seminar, lectures were delivered on clinical trials, consultations, product reviews, package inserts, safety measures, risk management plan (RMP), the relief system for sufferers from adverse drug reactions and capacity building (see agenda for details).
In addition, group discussions on consultations and product reviews, presentations by the participants on drug regulations of their regulatory authorities, lectures by industry representatives, etc. took place and the participants actively engaged in discussions throughout the seminar.
Over 15 staff members from PMDA provided lectures and aided the group works.
At the end of the seminar, the Course completion certificates were handed to each one of the participants by Dr. Tatsuya Kondo, Chief Executive, and overall comments by Dr. Toshiyoshi Tominaga, the Associate Executive Director for International Programs.

Photos and participant comments

Seminar 2016_01

<Lectures by PMDA staff members>  Participants enthusiastically asked many questions.
Comments from participants:
“The presentation includes lots of information about the organization and how the organization work. It’s really helpful.”
“The seminar is well organized that cover the major work of what PMDA do. It also let me understand the rationale behind the decisions PMDA made. Eg. How they review and approve a drug or clinical trial.”
“This seminar is very useful for us, especially for me. I get a lot of new knowledge. Thank you for giving us chance to attend this seminar.”

 Seminar 2016_02     Seminar 2016_03


<Group work session> Group work sessions are one of the key sessions of the Seminar.
The case studies provided the opportunity to discuss with other regulators on the important points to keep in mind during the product review.
 Comments from participants:
“Today’s “Product Review” case study was really good. We had a lot of discussion in this session. Through this discussion, I know about the other countries review comment. And PMDA reviewer also gave us some hints and help. Thanks to PMDA reviewer and all of the member in my group. I really learned a lot.”
“Case study makes the theoretical explanation much much clearer.”
“Through case discussion, we can further understand the meaning of the consultation.”
“This section gave us the chance to discuss the implementation of trial consultation.”

<Group photo at the closing ceremony>
Seminar 2016_04
Each participants received a certificate of completion from Dr. Kondo

Overall comments from the participants

“Thank PMDA to give me this chance to join this seminar. It is really helpful to my work and I really learned a lot. I was very interested in the session about “consultation” and “product review”. The “case study” also let me understand the different opinions in different countries”
“I think this is very meaningful exchange. We need to learn from PMDA. We will be actively involved in iternational activities.”
“The seminar provides a good coverage of the various scope which is relevant to our work.”

PMDA-ATC Seminars are held periodically, with a different theme for each seminar.
The Seminar announcements are posted on PMDA's Events and Symposia website.
For any questions regarding PMDA Training Seminar, please contact us by clicking on the “Contact us” logo on top of the website, or please contact the Secretariat, PMDA-ATC@pmda.go.jp


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Chiyoda-ku, Tokyo 100-0013 Japan

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