Japan's New Medical Device GCPs

Why Should I Take This eConference?
Because clinical trial data must be in compliance with Japan's new medical device GCPs, no matter where the trial was conducted.

 

Objective:
To learn the new requirements for clinical trials in Japan.

 

Description:
Japan has a new medical device GCP regulation and it is different from the ISO or US standards. Revised in 2005, the regulation was followed by several supplemental notifications. This e-conference consists of a comprehensive overview of the present state of affairs. As an added value, you will receive  an English version of the Japanese MHLW notice on how to handle clinical data obtained outside of Japan.

 

You will learn:
- Learn what led up to the new GCPs.
- Understand the requirements and the points that need special attention.
- Identify the responsibilities of the sponsor, investigator(s), and clinical site(s).
- Discuss the acceptability of foreign clinical data.

 

Presenter:
Ms. Nobuko Matsunaga, Chief Regulatory Officer of Japan MDC--a Japanese regulatory and marketing consulting firm specializing in medical devices--has a Bachelor of Chemical Engineering and is experienced in medical device regulations. With more than 10 years work experience she became an independent freelance regulatory consultant which led to the establishment of Japan MDC together with Kunihiko Mitsuda.  Ms. Matsunaga can be reached at nobuko.m@j-mdc.com

The purchase is $402 for the CD. Event materials are available on the CD itself. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.