Berichten

Atomium Brussels

Inaugural RAPS Regulatory Conference Europe 2019 in Brussels

The inaugural Regulatory Affairs Professionals Society (RAPS) annual Regulatory Conference Europe was organized in Brussels, 13-15 May 2019. The next Convention will be held again in Brussels in May 2020.
At this first European Convention more than 300 regulatory professionals participated. MARACA International helped organize a strong European program covering regulatory topics in pharma, medical device and IVDs fields. The European Commission, Competent Authorities and Notified Bodies were well represented. The EU Commission representative gave an update on the roll out of the MDR and the IVDR.
Dr. Luc Van Hove organized a session on SME concerns with the transition of their IVDs to the IVDR. We had an audience of 50 participants and good discussions on what the stuck points are for SME while migrating their IVDs to the new IVDR. Key issues were available notified bodies; How can the equivalency road be used; What is sufficient clinical evidence; How to run a Post-market Performance study.