When the new European In Vitro Diagnostic Regulation (IVDR) becomes applicable, the ability to utilize in-house or Laboratory Developed Tests (LDTs) will be much more restrictive in Europe. The testing landscape for companion diagnostics (CDx) will change, and pharma, molecular laboratories, and diagnostic providers need to ensure that patients have access to regulated tests. This webinar is specifically for those working in pharma business development, CDx alliance management and CDx commercialization management, project management and clinical trial management. Join us to learn what clinical data need to be generated to meet IVDR requirements for CDx, how clinical trial programs may be impacted and how to make an IVDR-compliant CDx accessible to patients throughout Europe.

Featured Speaker

Dr. Maurizio Suppo

Co-owner & Principal Consultant
Qarad BV

Maurizio Suppo obtained his Ph.D. in molecular biology from the University of Turin, and has held a variety of executive positions in the field of regulatory affairs and quality systems in the in vitro diagnostic industry. He has been the Director of the European Diagnostic Manufacturers Association (EDMA) and, in that role, he represented the IVD industry position in the drafting of the European IVD Directive 98/79/EC. His knowledge and experience in RA & QS go beyond the European borders.

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