The medical device sector is undergoing significant change in Europe with the new Medical Device Regulation ready for implementation and HTA Regulation under discussion. This complex and rapidly evolving environment poses important challenges at all stages of the lifecycle of medical devices. What are the immediate consequences of the introduction of the new European Regulations (MDR, HTA)? How is the HTA of medical devices evolving at European level? What clinical and economic evidence needs to be generated? How, when and by whom should it be evaluated? Will digital technologies (mHealth) be evaluated with the same methods and processes as medical devices? Will the methods of purchasing medical devices change (innovation procurement)? Will reimbursement policies include innovative formulations (bundled payment)? These are some of the questions that the course aims at answering through the alternation of theoretical lessons, concrete case studies and video-interviews with the main actors of the system. The course is shaped by a faculty team with consolidated theoretical and practical experience in the medical device sector and several key opinion leaders from European organizations.
Skype Chat with the Direction
Please write to the course Directors to book your place and arrange your time slot.
Ludovica Borsoi, Ludovica Borsoi, SDA Junior Lecturer, Government, Health and Not for Profit – Program Director - Skype ID: ludovica.borsoi, mailto: firstname.lastname@example.org
Rosanna Tarricone, SDA Associate Dean, Government, Health and Not for Profit – Program Director - Skype ID: Rox697, mail: email@example.com