Tuesday, 21 December 2010

Post-market surveillance and vigilance for diagnostics

Thermo Fisher Scientific today announced that Colin Booth, director regulatory affairs – microbiology (Oxoid and Remel brands), will speak at the forthcoming European Diagnostic Performance Evaluation & Regulatory Conference, to be held in Brussels, Belgium January 24-25, 2011.

The conference theme is “Understanding and Appreciating the Evolving Regulatory Path for Diagnostic Tests and the Clinical Challenges in Sample Size and Design to Support European Regulatory Approvals.”
The event will bring together diagnostic manufacturers from small and large companies and, representatives from Notified Bodies and Competent Authorities to discuss and debate the best methods for meeting both regulatory requirements and internal corporate goals.

In recent years, European Notified Bodies and Competent Authorities have placed increasing emphasis on post-market surveillance for diagnostic clinical studies and products. Competent Authorities have paid specific attention to self-certified IVD manufacturers by conducting inspections to ensure that surveillance systems have been implemented and maintained. With the rising regulatory complexity in the EU, diagnostic companies are forced to invest ever increasing amounts of time and resources to remain compliant and handle requests from authorities.

On Tuesday, 25 January, Mr Booth will talk on the subject of “Post-Market Surveillance and Vigilance for Diagnostics.” He will cover clinical and regulatory surveillance system responsibilities and liabilities, communication challenges between clinical and regulatory teams and Competent Authorities, lack of standard approach and centralized surveillance. He will also discuss the future of Eudamed.

Thermo Fisher Scientific