RAPS is the largest global organization serving regulatory professionals and the regulatory profession worldwide.

The RAPS Regulatory Conference – Europe 2019 is the inaugural conference designed by European regulatory affairs professionals for European regulatory professionals, and where the regulatory community gathered to discuss the most pressing regulatory topics, share experiences and network with other stakeholders.

A wide range of current issues facing medical device, IVD and medicines regulatory professionals were covered at the 2019 event, as well as general subjects that impact all professionals in the healthcare product space.

Donawa Lifescience Consulting (DLC) participated in the Conference, specifically in the session dedicated to In Vitro Diagnostic Devices. DLC’s President, Maria E. Donawa, M.D., chaired a session titled ‘Clinical Evidence and Clinical Performance Study Requirements Under the New European IVD Regulation’, taking place on the morning of the first day, ​​​and Daniela Karrer, DLC’s Director of Clinical Affairs, presented on new requirements in the IVDR for clinical performance studies.