Revisions of Japan GCP Regulations

Learning Objective
In this e-conference you will learn the current status on the revisions of the Japan Good Clinical Practices regulations and how they apply to your clinical trials and product submissions.

Japan GCP Revisions in Progress
The Ministry of Health, Labour and Welfare (MHLW) is working to revise GCP regulations for medical devices. If you plan to conduct clinical trials in Japan or to submit a medical device application with data from the US, this e-conference is critical to understand the situation there.

The Essential Details
In this informative and useful event, Ms. Nobuko Matsunaga will present the most recent news on Japan’s GCP revisions. She will cover: [x] the requirements to conduct clinical trials in Japan in terms of a GCP audit with documents, facts, and examples, and
[x] situations with case studies in which clinical data collected in the US can be used for submission in Japan.

The Whole Picture
You will understand the direction of Japan’s GCP and how Japan’s authorities conduct a GCP audit.

You will receive:
[x] PowerPoint Slides.
[x] Up-to-date information on Japan GCPs.
[x] An expert speaker.
[x] A chance for Q&A.
[x] CEUs & Certificate.

Presenter:
Nobuko Matsunaga is Chief Regulatory Officer at Japan Medical Device Consulting. In addition to the daily work of regulatory consulting, she also contributes to improving the regulatory environment in Japan as a member of the regulatory sub-committee of the European Business Council of Japan. You can reach Ms. Matsunaga at nobuko.m@j-mdc.com or www.j-mdc.com.

The purchase is $422 for OnDemand access and $472 for the CD. Event materials are available by download for OnDemand or are 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.