Voisin Consulting Life Sciences publication icon
PublicationMedical Device

Biomarkers qualifications: a first step towards companion diagnostic development

Post thumbnail Biomarkers qualifications: a first step towards companion diagnostic development

Biomarker qualification can be a first step towards companion diagnostic development. The European Medicines Agency already has a biomarker qualification process and the US Food and Drug Administration is developing one itself. The two agencies should find a way to harmonise their respective processes and propose clear incentives for companies seeking to use them.

Sabah, Malek, Sylvie Le Glédic, Anne Dupraz-Poiseau
Biomarkers qualifications : a first step towards companion diagnostic development

2011 – SCRIP Regulatory Affairs

Voisin Consulting Life Sciences download icon

Download the full publication now

Fill in the form to download the content

    Yes, I would like to receive communications regarding VCLS services and events

    publication by

    Sylvie Le Glédic, PhD thumbnail
    Sylvie Le Glédic, PhD
    Director, Medical Devices & IVD
    Sabah Malek thumbnail
    Sabah Malek
    Senior Regulatory Scientist Medical Devices and In Vitro Diagnostics
    Anne Dupraz Poiseau thumbnail
    Anne Dupraz Poiseau
    Executive Vice President

    Voisin Consulting Life Sciences widget icon All our resources

    all our Resources

    More resources

    Voisin Consulting Life Sciences
    Powered by  GDPR Cookie Compliance
    Privacy Overview

    This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.