Welcome to the second webinar on How to Commercialize your Biomarker Discovery – a free webinar series focusing on the biomarker commercialization process. The focus of this second webinar is on European IVD Regulation and the regulatory requirements for biomarker development and commercialization, important know-how for any research group, SME or TTO working with biomarker development.
- 13:00-14:00 CET
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
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.