From December 6 to 8, 2021, PMDA held a webinar entitled “PMDA-ATC Pharmaceuticals Review Webinar 2021“.
This webinar was intended for officials of overseas regulatory agencies involved in the review of pharmaceuticals. A total of 34 regulators from 12 countries/regions: Brazil, Ethiopia, Hong Kong SAR - China, India, Indonesia, Myanmar, Philippines, Saudi Arabia, South Africa, Taiwan, Thailand and Uganda joined the webinar.
Before attending the webinar, the participants of the webinar took the PMDA-ATC E-learning course, “Pharmaceuticals Review“ covering such topics as; toxicology studies, first in human studies, good laboratory/clinical practice, review of generic drugs/biosimilars, expedited regulatory pathways, etc., as the preliminary training.
The live lectures covered topics of; new drug approval review, consultation meetings, regulatory challenges against COVID-19 and review of chemistry, manufacturing and control (CMC). The participants actively engaged in the Q&A session after each lecture. (See agenda for details)
On the 2nd and the 3rd day of the webinar, case study group discussions on the themes of review of new drugs and review of generic drugs, respectively, were held to deepen participants’ understanding.
The webinar live session opened with the remarks by Mr. UZU Shinobu, Director of PMDA-ATC, and by Dr. ASAKURA Wataru, Director of Office of New Drug I and the Senior Coordinator, responsible for the Pharmaceuticals Review Seminars.
At the end of the webinar, Dr. FUJIWARA Yasuhiro, Chief Executive of PMDA gave a word of congratulation and handed certificates to the participants virtually, in a recorded message, and Dr. SATO Junko, Director of Office of International Programs, gave a closing remarks.
< Opening and closing >
< Lecturers >
Comments from the participants:
< Lectures >
“The introduction of drug review process is very clear, and PMDA plays an important role between applicants and external experts.”
“Very clear, the consultations in different stage of clinical phase resolve every kinds of questions.”
“This training has improved how I will review applications especially on data regarding COVID19 vaccines.”
“Now, I understand clearly what pharmaceutical review is, what kinds of knowledge are essential for reviewer.”
< Case studies >
“The session was very helpful for us as Pharmaceuticals Evaluators. It enables us to review data and have other NRA’s perspective including PMDA’s take on pharmaceutical evaluations.”
“It is very informative especially BE, thank you for sharing the critical point to consider generic drugs.”
“I have learned valuable information, and I thank PMDA to give us the opportunity to learn and share our knowledge across the globe.”
“The material is well-detailed and the topic for discussion is perfect as well.”
“The webinar is very organized and well executed. I am very delighted with the Q&A portions.”