Preparing the Clinical and Regulatory Master Plan

Developing an accurate clinical and regulatory master plan is the key to getting any new drug or device product to the global marketplace quickly and in a cost-efficient manner. The master plan provides an invaluable roadmap of what needs to be done, and will also be used as a business plan in dealings with your notified body and potential investors. In this audio conference, our speakers discuss not just planning for CE marking, but incorporating the overall global market access into one plan. Attendees learn how key parameters and claims are defined, which is an important starting point.

The presentation also covers how to ensure compliance throughout the regulatory pathway to the global market, and how to ensure there is sufficient data available for immediate success of your products in global markets.

Preparing the Clinical and Regulatory Master Plan is being presented by Efraim Roe Kozorovitsky & Dr. Sunita Ahir, Executive Director, Medical Devices & Manager, Regulatory Affairs, with Premier Research and airs on Thursday, September 24, 2009. For more details or to register, please visit our site at www.fxconferences.com