Risk management plans – one year on from the EMEA guidelines

Abstract

In November 2005, the European Medicines Agency, the EMEA, published its guidelines on risk management plans (RMPs). Just under a year later, in order to aid consistency of the format and content of such plans, the EMEA released a template for companies to use when submitting what have become known as 'EU-RMPs'. It was therefore timely that the topic of one of this year's pre-conference training sessions at the 6th Annual Meeting of the International Society of Pharmacovigilance [Liege, Belgium; October 2006] was RMPs.1 ^, 2