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Welcome to Advanced Medical Technology's "virtual" risk management newsletter, Risk Review! Within the pages of this publication, you will find information to help you better understand the unique risk management issues associated with the medical products and research services industry. Since the process of bringing new products to market is long, complex and expensive, it is the goal of this publication to bring you information that will help you better understand and control the risks associated with that process.
Inside you will find material on subjects that are basic to the product development process, such as informed consent, clinical trials, FDA inspections, and more. You will also find discussions about current risk management issues that impact the medical products and research services industries in important areas such as product liability
The materials found in Risk Review come from authors with experience in the biopharmaceutical and medical device industries.
When you first visit, please fill out our Customer Survey. We want this publication to provide you with useful information, so we need your input! If there are other regulatory topics or risk management issues you would like to see discussed, let us know.
We are providing this value-added service to you, our customers, because we believe that good regulatory compliance is an important component of good risk management. Remember, however, that these materials are only designed to give you an overview of the issues, and are subject to interpretation. For specific information and answers on any of these topics, you should consult with your legal counsel, in-house regulatory affairs professionals, or the Food and Drug Administration (click on the Resources button to access the FDA url).
In addition to information on regulatory issues, in the future we plan to bring you information on other traditional loss-control activities. We hope you will enjoy reading our educational publication, and that you will consider this service a useful resource you will visit over and over again.
The information contained herein is not intended to serve as legal advice. The sources used to develop this information are believed to be reliable, but CNA accepts no responsibility or legal liability for the correctness or completeness of this material or for its application to specific factual situations. Specific legal concerns or questions should be directed to individual competent counsel. As appropriate, you may also wish to contact the Food and Drug Administration for more specific or complete information. CNA is a registered service mark and trade name of CNA Financial Corporation. Links to other internet sites that are not maintained by CNA may be accessed through this web site. Such external internet addresses contain information created, published, maintained or otherwise posted by organizations and entities independent of CNA. CNA is not responsible for the content of those sites nor does it approve, endorse or certify information available at any external site or linked addresses contained herein. No part of this site may be reproduced without written permission from CNA. Material may be reprinted upon proper attribution to CNA and inclusion thereon of the words ©2000 by the CNA Financial Corporation.
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