Medical writing for two audiences – The RMP public summary

Abstract

With the introduction of the new EU Legislation in 2012, RMP requirements have changed significantly, triggering content- and process-related changes. An RMP is written as part of a submission dossier and is submitted for assessment to the EMA. The most important information is outlined in Part VI of the RMP, which forms the basis for the summary that is subsequently published on the EMA website. For medical writers the task of writing for expert and lay audiences at the same time poses new challenges.

Keywords:

• Risk Management Plan (RMP)
• RMP summary
• Lay audience
• EMA website
• RMP Part VI

Additional information

Notes on contributors

Kerstin Prechtel

Kerstin Prechtel is a Senior Safety Writer at Boehringer Ingelheim Pharma GmbH & Co. KG. She has almost 10 years of medical writing experience in the pharmaceutical industry in various domains of medical writing, including regulatory writing, clinical writing, and safety writing (with extensive hands-on experience on the EU Pharma Package and its initial implementation).

Stefanie Rechtsteiner

Stefanie Rechtsteiner is a Senior Safety Writer at Boehringer Ingelheim Pharma GmbH & Co. KG. She has worked for more than 12 years in various fields within the pharmaceutical industry, and has specialised in safety writing since 2011. She has extensive hands-on experience on the EU Pharma Package and its initial implementation.