Risk management plans beset with challenges
Although the risk management plan (RMP) is a centerpiece of the European Union’s efforts to boost confidence in the safety of new drugs, its benefits are less certain than the problems it poses.
Consider this: out of 12 RMPs the EMEA examined to review the requirement, only three proved acceptable. Virginie Lefebvre-Dutilleul and Frank Kumli, Ernst & Young, suggest that one way companies can improve their submissions is to take an enterprise-wide approach to the development, implementation, and monitoring of RMPs. In this article, they provide a brief summary of the implementation challenges pharmaceutical companies may be grappling with and present a list of questions executives can use to coordinate their RMP submission.
Download full article "Europe’s risk management plans — beyond pharmacovigilance" (pdf, 93kb).