You will understand that the new European IVD Regulation includes for the first time companion diagnostics and that additional requirements applying. The definitions of companion diagnostic (CDx) are reviewed. US and EU CDx are compared. An overview of the CDx field is given. What the hurdles are in setting up a CDx program by pharma and IVD companies. How a successful CDx program is developed. What the benefits are. What the new process steps are per the IVDR for Authority review. What the EMA and NB roles are. What it means to collect clinical evidence for a CDx. What the general requirements are for clinical studies and the additional requirements for CDx clinical studies. How the development pathways of the drug and the IVD relate to each other. Finally, how misunderstandings are prevented through negotiations and a strong contract. A lessons learned concludes this e-learning course.
2 hours to understand and practice content
E-Learning, includes examination
Price excluded 21% BTW