CLIA Waiver Submissions – Common Mistakes, Recent Trends and FDA's Plans for the Future

is being presented by Dr. Gail E. Radcliffe, President, of Radcliffe Consulting and airs on Tuesday, September 20th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com

Rapid test results in point-of-care settings enable clinicians to act immediately with appropriate treatment. However, personnel conducting these tests are not trained as laboratory technicians, so FDA requires demonstration – via submission of a CLIA Waiver – that these tests are simple and have a low risk of reporting erroneous results. In this audio conference presentation, our speaker provides insight on what should be included in a CLIA Waiver, and what sorts of tests qualify for this treatment. The presentation also reviews the most common mistakes made by diagnostics companies in their CLIA Waiver submissions, and takes a look at some recent trends and FDA's future goals in this area.

In-Vitro Diagnostics: Testing Times

is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Thursday, September 8th, 2011. For more details or to register, please visit our site at www.fxconferences.com

The regulations relating to the testing of new in-vitro diagnostic tests are not always clear. There are various regulations that require compliance: the In-Vitro Diagnostics Directive in the EU, ISO standards, and the US regulations. There is the added complexity of CLIA waivers in the US for those IVDs designed to be used outside the laboratory setting.

In this audio conference, the speaker will describe and review the regulations that govern the testing and approval of new in-vitro diagnostics in the EU and USA. Performance testing and CLIA waiver studies will be included. The aim is to clarify the requirements and assist in the design of any clinical testing that may be required.