Within the past few months, both FDA and ISO have issued updated regulatory guidance relevant to the monitoring of medical device trials. The FDA issued its draft guidance in August 2011, recommending a risk-based approach to monitoring. Meantime, the latest version of the ISO 14155 standard was also issued in 2011. It describes Good Clinical Practice for medical device trials, and it is an international standard, accepted in most countries. It includes guidance on monitoring and, ironically, leans towards a high proportion of on-site monitoring visits to assure data quality.

In this presentation, Dr. Helen Colquhoun provides an overview of the two guidance documents, and shares best practices for monitoring medical device trials. The presentation includes examples of citations in FDA warning letters for failure to monitor medical device studies correctly, in order to identify some common pitfalls during monitoring.

This audio conference covers:

• The latest FDA and ISO guidance governing the monitoring of medical device clinical trials in the USA and EU
• How to implement a risk-based approach to monitoring
• Examples of monitoring issues that prompted FDA warning letter citations
• How to write the “perfect” monitoring plan for medical devices studies

About the speaker:

Dr. Helen Colquhoun 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 Inc, 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