Plain language is not just for leaflets
It’s not just leaflets that need to be understood. The lay-language summaries of risk management plans (RMPs), required under the most recent pharmacovigilance legislation, are a tricky area. Because they need to be scientific summaries in patient-understandable form, there is no quick and easy solution. However, because of our years of experience of putting complex truths in simple language, we can help.
Similarly, the Summary of Product Characteristics (SmPC) has come under fire recently. A high-ranking EMA official has been heard to say they didn’t worry too much about them, and accepting that they are not often read. The SmPC is of course the basis for the package leaflet, and the official thinking about their potential may need to change in the face of some research in BMJ Open: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3753505/pdf/bmjopen-2013-003033.pdf
Whether you want to polish up RMPs or SmPCs, drop us a line or give us a call.