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Audio conference highlights

The FDA publishes warning letters on its website, and these are increasingly concerned with the monitoring of medical device clinical studies. It is clear that some device manufacturers are finding it difficult to comply with the FDA's current guidance and regulations governing the monitoring of medical device clinical trials. In Europe, monitoring standards are similar but there is often a lack of clarity of what is expected because the audience for the clinical trial application (the competent authorities) and the CE marking dossier (the notified bodies) is different.

In this presentation, Dr. Helen Colquhoun summarizes the regulations and official guidance governing the monitoring of medical device clinical trials in the USA and EU. She also provides the audience with the essentials necessary to ensure compliance with these regulations, including giving practical examples of what monitors need to do at site. Dr. Colquhoun also covers how to deal with difficult investigators and sites that are unwilling to comply with regulatory standards. A discussion follows on the consequences of non-compliance, as well as how to prepare for a monitoring audit by the FDA. Dr. Colquhoun also discusses how clinical research departments need to be resourced to deal adequately with monitoring demands. The presentation is illustrated by real-life examples.

This audio conference covers:

• The current regulations governing the monitoring of medical device clinical trials in the USA and EU
• What monitors need to do at site to ensure compliance with these regulations
• The implications for trial sponsors of non-compliance
• How to prepare for an FDA monitoring audit
• How to staff clinical research departments to adequately monitor studies

About the speaker:

Helen Colquhoun, MD holds degrees in Genetics and Medicine from the University of Edinburgh and spent several years practicing clinical medicine before entering the life science industry in 1988. Helen spent seven years working with a major pharmaceutical company before setting up as an independent consultant in 1995. Since that time she has spent increasingly more time working with medical device and drug delivery companies.

In 2000 she co-founded the Pleiad group of companies and is currently CEO of Pleiad Devices, a clinical research organization based in the USA and Europe that specializes in clinical research and regulatory support for medical device companies. Helen runs Pleiad's North American operation and is based in Cambridge, Massachusetts.

Who should attend?

• Clinical Research Managers
• Clinical Research Associates
• Clinical Research Monitors
• Regulatory and Compliance Department Managers
• Regulatory and Compliance Associates

This conference is rated General interest