2021/11/21
Information for our guests:
Date Wed, 17-Nov-2021
Start 12:00
End 13:15
Venue Virtual
Guests Fee (Yen) 1,200
Speaker(s) Yasuhiro Fujiwara (Chief Executive Pharmaceuticals and Medical Devices Agency (PMDA)).
Registration Deadline Tue, 16-Nov-2021 12:00
Description:
Cutting-edge innovation and unprecedented medical needs are challenging governments to rethink traditional regulatory systems—whether this is the emergency use authorization of diagnostics, medicines, and vaccines to cope with a pandemic or the approach to regulating cutting-edge technologies such as so-called software as a medical device (SaMD).
On November 17, Dr. Fujiwara, chief executive of Pharmaceuticals and Medical Devices Agency (PMDA), joins us in a presentation that promises to provide healthcare company representatives with a rare opportunity to learn about the future course of PMDA and regulatory science in Japan. He will share his thoughts on recent developments in regulatory science, reflect on Japan’s response to the COVID-19 pandemic, and highlight ongoing efforts to compile an evaluation index for SaMD and introduce a pilot-based Sakigake system for such products.
We look forward to having Dr. Fujiwara join us in an interactive discussion as Japan continues its efforts to achieve world-class regulatory excellence.
Information source: http://www.accj.or.jp/accj-events
