The European and US regulatory authorities recognize the potential of biomarkers to support the clinical and nonclinical development of medicinal products. Guidelines to clarify regulatory expectations have been published and both EMEA and FDA have developed procedures for companies to obtain input and advice on biomarker development. Importantly, those same regulatory authorities have both also formalized qualification procedures that result in an opinion on the acceptability/suitability of a biomarker.
This audio conference provides an overview of the EU and US biomarker qualification procedures. The speaker explains the steps involved, the data package required, and provides insight into why going through these procedures can add significant value with regards to investment opportunities, partnering and licensing deals.
Regulatory Framework to Support Biomarker Development: EU & the USA is being presented by Dr. Patricia Hurley, Head of Project Management and Biomarkers Division, with ERA Consulting (UK) Ltd. and airs on Thursday, January 21, 2010. For more details or to register, please visit our site at www.fxconferences.com
