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, our speaker describes and reviews the regulations that govern the testing and approval of new in-vitro diagnostics in the EU and USA. The presentation includes discussion on performance testing and CLIA waiver studies, and helps clarify for attendees the various requirements, as well as design considerations for any clinical testing that may be required.

This audio conference covers:

• The regulations and guidance governing the testing of new in-vitro diagnostics in the EU and USA
• The regulations and guidance relating to obtaining CLIA waivers
• The design of any clinical testing that may be required

About the speaker:

Dr. Helen Colquhoun is CEO of Pleiad Inc, a full-service medical device and diagnostics CRO. She has worked in the medical device and pharmaceutical industries for more than 20 years. She is a physician with a depth of experience in vigilance, pharmacovigilance, regulatory affairs, clinical study design and management, and product development planning. Her expertise covers North America and Europe. She is based in Cambridge, Massachusetts.

Who should attend?

• Regulatory Specialists
• Clinical Specialists
• Quality Specialists