Rory is the Senior Director of Regulatory Affairs at Mapi, he has 25 years of experience in the heathcare Industry to devise and execute tailored regulatory solutions for clients. Expertise provided in EU Scientific Advice pathways, parallel SA-HTA meetings, Orphan Designations, Paediatric Investigation Plans, MAAs and variations - Centralized, MRP, DCP, and WSP, CTAs and disclosure, and the integration of HTA requirements into the development path for pharmaceuticals and medical devices.
13:40 – 14:30Partnering with patients for clinical success
14:30 – 15:30Methodologies in developing Real World Data: Engaging stakeholders in developing evidence strategies
16:00 – 17:00An introduction to the science of endpoint design in the current regulatory and HTA environment in the US and Europe