Publication date:
15/06/2011
Publication ref:
The ABPI Pharmacovigilance Expert Network (PEN) think that safety data from non-company sponsored websites is not being fully utilised for the purposes of public health protection due to the lack of guidance on this topic. New drug safety legislation was approved in the EU in December 2010 and the implementing guidance for the legislation is being drafted in time for its implementation in July 2012. We hope to influence the drafting of this implementing guidance with this paper.
Document size: 350KB