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Report of the PMDA-ATC CMC/GMP Seminar 2019 in Hanoi, Vietnam

PMDA-ATC CMC/GMP Seminar 2019 in Hanoi, Vietnam

Pharmaceuticals and Medical Devices Agency (PMDA) recently completed the PMDA-Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) CMC/GMP Seminar 2019 in Hanoi, Vietnam on October 9, 2019. This seminar was designed for regulators from Vietnam. Total of 33 regulators from Vietnam (10 Drug administration of Vietnam (DAV) staff and 23 external experts) joined the seminar.

The seminar opened with remarks by Dr. Nobumasa Nakashima (Senior Director of International Programs, PMDA). The lectures topics on the Review of Chemistry, Manufacturing and Control (CMC) and Good Manufacturing Practice (GMP) inspection were provided by staff members from PMDA and DAV. In addition, group works were actively conducted with case studies of GMP inspection. The participants eagerly listened to the lectures and discussed in the case study (see agenda for details).

In total, 4 trainers, including 2 staff members from PMDA, contributed to the lectures and case studies.
On the final day of the seminar, the Course completion certificates were handed to participants by Dr. Nobumasa Nakashima (Senior Director of International Programs, PMDA).

Photos and participant comments



Comments from participants:
For the session on Review of CMC:
“I understand that specification and control of manufacturing are important”

For the session on Overview of GMP:
“The trainer provided good information and shared the experience of GMP inspection from Japan”

<Case study>


Comments from the participants:
“I could improve my knowledge about risk-based GMP inspection”

“Case study is very useful and easy to understand”

<Group photo>

Overall comments from the participants

“The seminar is very useful, provides properly information.”

“Your presenters have a lot of experiences. I hope I could join further training course in the future.”

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).

Note: For the purpose of security, @ in the e-mail address is replaced with ●. Please replace ● with @ when you send an e-mail.

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