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International regulatory harmonisation meeting in the US

This article was originally published in Clinica

Executive Summary

The regulatory conference Creating a globally harmonized quality system will take place during March 9-11 2009 at the Westin Hotel in Las Vegas. The event’s focus is best practices for creating and auditing a globally harmonised quality system and will be of special interest to those who sell devices or IVDs in multiple international markets. Senior- level speakers at the event will be Evangeline Loh, Jaap Laufer and Julie Powell of the Emergo Group regulatory consultancy. Other speakers will hail from the US FDA and industry leading companies such as Boston Scientific, Guidant and Hitachi. Some of the topics to be covered, are: challenges in complying with the FDA quality system regulation; lessons learned in synchronising a quality system that complies with US and Japanese requirements; FDA's expectations for device firms with international facilities; and an exercise on challenges of working with notified bodies. For further information and to register, go to:

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