EU regulation

A new law adopted on Wednesday aims to avoid duplicating national assessments to determine a treatment’s added value that help EU countries decide on pricing. Read more


The Regulatory Affairs Professionals Society (RAPS) is launching its first European Council (REC) to support its expansion and to increase its presence within the region. Read more


Bruno Speder, SGS Life Sciences, gives an overview of new EU regulation 536/2014, introduced to provide a single European submission and approval procedure for clinical trials, and discusses the effects it may have on early phase clinical trials Read more