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EU regulation

Senior professional support lawyer Paul England and Matthew Royle, partner in the life sciences team at international law firm Taylor Wessing discuss what the introduction of a manufacturing waiver to the SPC legislation means for manufacturers. Read more

, Opinion

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

News

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

News

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

Opinion