Tijdens dit twee daagse programma ligt de aandacht op de voordelen en uitdagingen die gepaard gaan met de ontwikkeling en toelating tot de markt van personalized medicines en de bijbehorende IVD voor bedrijven in de Europese Unie.

 

Deelname is gericht op de volgende aspecten:

• to explain the unique challenges of the development, licensing, and market access of personalized medicines
• to identify the critical elements in the co-development of drug and device, and the commonalities or differences between the EU and US requirements
• to develop or contribute to a regulatory strategy for the development of a personalized medicine IVD combination
• to understand the nuances of market access

• mid- to upper-level regulatory affairs professionals (both in pharma/biotech and device/IVD industry)
• ataff at regulatory agencies and Notified Bodies
• persons involved in the clinical development targeted pharmaceuticals
• researchers involved in the identification and validation of biomarkers
• project managers
• professionals in market access

Inschrijven kan via de website van RAPS www.raps.org