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Report of the PMDA-ATC Medical Devices Webinar 2020

PMDA-ATC Medical Devices Webinar 2020

From November 16 to 20, 2020, PMDA held a webinar entitled “PMDA-ATC Medical Devices Webinar 2020“. PMDA was formally endorsed by the Asia-Pacific Economic Cooperation, Life Sciences Innovation Forum, Regulatory Harmonization Steering Committee (APEC-LSIF-RHSC) in June 2020, as the Center of Excellence (CoE) in the medical device area, and the webinar was the first CoE workshop since the endorsement.
 
This webinar was intended for officials of overseas regulatory agencies involved in the review of medical devices or in vitro diagnostics (IVDs). A total of 27 regulators from Azerbaijan, Bahrain, Botswana, Brazil, Chile, India, Indonesia, Malaysia, Myanmar, Oman, Peru, Philippines, Saudi Arabia, South Africa, Sri Lanka, Taiwan, Thailand and Zimbabwe joined in the webinar (see agenda for details).
 
Recorded lecturers by PMDA staff members, representatives from National Cancer Center and Clinical Research Administration Center of Tohoku University Hospital were provided in advance of the webinar, as the preliminary training materials.
 
The recorded lectures covered biological safety, Quality Management System (QMS) and Medical Device Single Audit Program (MDSAP), international standardization, and registered certification bodies, which then were followed by the live Question and Answer sessions on the 1st and the 2nd day, in which the participants actively engaged in all the discussions.
 
From the 3rd through the 5th day, the participants were divided into 5 groups and engaged in the case studies provided by PMDA on such topics as Review and Approval of Medical Devices and In Vitro Diagnostics (IVDs), and Post-market Safety Measures for Medical Devices. Then the representative from each group presented the results of the discussion to all the participants. The participants deepened their understanding throughout the group works.
 
The webinar live session opened with the remarks by Mr. UZU Shinobu, Director of PMDA-ATC, Dr. NAKASHIMA Nobumasa, Senior Executive Director and the incumbent Co-Chair of APEC-LSIF-RHSC and Dr. ISHI Kensuke, Director of Office of Medical Devices I.
 
 At the end of the seminar, Dr. FUJIWARA Yasuhiro, Chief Executive of PMDA handed the course completion certificate to each participant virtually by recorded video, and Dr.SATO Junko gave the closing remarks.
 

Photos and participant comments

<Opening and Closing>


<Lecturers>


<Participants>
 


Comments from the participants:

< Recorded Lectures and Q&A sessions >

“The session was well prepared, well delivered and well understood.”
 
“The advance lecture and question and answer on the date of the lecture itself is very nice and time efficient”
 
“Very informative interaction between the participants and the experts.”
 

< Case studies >

“Excellent discussion and interpretation as well as new information added.”
 
“Group discussion and Q&A session was very interactive, this training session impart knowledge about current regulatory practices in training joining countries. “
 
“Very good topic and case study to discuss. The explanation was clear and quiz answers also explained clearly.  I wish time would be long enough to discuss more case studies”
 

Overall comments from the participants

“The webinar was of excellent quality and impeccable organization. Lots of important information that will help us a lot. I would like to thank you for the opportunity of such important learning”

 “I appreciate the opportunity to participate in this webinar, it was very useful for me and my training as a professional, I reiterate my congratulations and gratitude.”

 “Overall we really appropriate the effort of preparing this webinar and we can see that lot of time was given to plan for this webinar.”
 

Information about future PMDA-ATC Seminars

PMDA-ATC Seminars are held periodically, with a different theme for each seminar.
The Seminar announcements are posted on this 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 (e-mail: PMDA-ATC●pmda.go.jp).


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