Risk management plans - New challenges for a new era
Lisa Chamberlain James · 2014
The risk management plan (RMP) is currently a hot topic and the focus of much discussion in industry due to the recent overhaul of the RMP guidance template. The complexity of the new RMP has introduced many challenges in preparing a high quality document compliant with all requirements – not least in the production of the newly legislated Part VI.2 (summary for the lay reader). This article discusses different aspects of the challenges posed by the new RMP, from an industry perspective of applying the new legislation and template, through to the importance of, and difficulties posed by, writing for the general public, and a comparison of the EU RMP with its US equivalent, the risk evaluation and mitigation strategy or “REMS”.