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.

This audio conference covers:

• Details of the new qualification procedures in Europe and the US
• Reasons for going through the procedure
• Data package requirements
• Incorporation into development and regulatory strategy
• Optimizing agency interactions and value added

About the speaker:

Dr. Patricia Hurley is the Head of Project Management and Biomarkers Division at ERA Consulting (UK) Ltd. She has significant experience in regulatory and product development issues with biomarkers and biological medicinal products in Europe and the USA. Patricia was formerly Principal Scientist at Epistem Ltd. and played a key role in developing their biomarker platform technology.

Who should attend?

• Regulatory Affairs Directors/Managers
• Project & Business Development Managers
• Senior Management
• Development Team Members
• Pharma Industry Investors

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.