Welcome to the second webinar on How to Commercialize your Biomarker Discovery – a free webinar series focusing on biomarker commercialization process
Focus of this second webinar is on European IVD Regulation and the regulatory requirements for biomarker development and commercialization, an important know-how for any research group, SME or TTO working with biomarker development.
Introduction to European IVD regulation – requirements for biomarker product development and commercialization,
Nelli Karhu, Senior Inspector, Finnish Medicines Agency FIMEA
14:00-14:30 CET Q&A
Moderator: Teppo Laaksonen, Network Manager, Turku Science Park Ltd
Please register here
NB: The IVD regulation is also covered in detail in the Biomarker Commercialization (BIC) toolset, designed to support, step-by-step, both academic researchers and SMEs when developing a biomarker-based invention to a commercial product. The BIC toolset includes a Biomarker Commercialization Guide, which covers technical, clinical, commercial and regulatory aspects, a Best Practices Handbook based on experiences from TTOs in the field, and a review tool for TTOs and a Guide for Regulatory Process. The toolset has been created in the BIC project funded by Interreg Baltic Sea Region Programme, and it will be available for free in summer 2020.