Pharmaceuticals and Medical Devices Agency (PMDA) recently completed the PMDA-Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) Pharmaceuticals Review Webinar 2020 for NPRA, Malaysia on November 6, 2020, in collaboration with the National Pharmaceutical Regulatory Agency (NPRA), Malaysia. This webinar was designed for pharmaceuticals reviewers from NPRA and 19 regulators joined in the webinar.
The webinar covered topics relating to the regulation and review process of pharmaceuticals, specially focusing on the First in Human (FIH) clinical trials and Good Clinical Practice (GCP) inspection, aiming at providing deeper insight into the present challenges in these areas.
In the webinar, the lecturers from PMDA and NPRA shared the information on the regulatory framework for FIH studies and experiences in GCP inspections, and the lecturers from Japanese academia and PMDA introduced the experience in FIH clinical trials and the pharmaceuticals review process involving FIH trials in Japan, respectively.
The webinar opened with the remarks by Mr. UZU Shinobu, Director of PMDA-ATC and by Dr. Zaril Harza Zakaria, Head of Evaluation & Safety of Investigational New Product Section, Centre of Product & Cosmetic Evaluation, NPRA.
At the end of the webinar, Dr. FUJIWARA Yasuhiro, Chief Executive of PMDA awarded the course completion certificate to each participant virtually by recorded video, and Dr. Zaril gave the closing remarks.
Comments from the participants:
“Good introduction to the regulatory framework and the GCP inspection in Japan.”
“Very clear presentation and good sharing of experiences in running FIH clinical trials.”
“Great sharing with expertise experience and detailed real case scenario.”
“It is a great experience, good platform of exchanging useful information.”
“The webinar is very useful and informative. It helps to broaden our knowledge in FIH study.”
“This webinar is very useful as a start for us to evaluate clinical trial application involving FIH.”
PMDA-ATC Seminars/Webinars are held periodically, with a different theme for each seminar/webinar.
The Seminar/Webinar 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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