Monday, 10 August 2015

The Risk Management Plan - an evolving document

In May this year I was fortunate to attend the European Medical Writers Association (EMWA) Spring Conference Symposium on risk management. Representatives from pharma, medical writing, the European Medicines Agency (EMA), as well as patient experts gave their perspectives on the risk management process currently in place. In Europe, a risk management plan (RMP) is required by the EMA as part of the approval process. As a medical writer, I've found the writing of these document to be a little challenging, particularly as the process and format is still evolving.
Here are some thoughts based on my experience of writing RMPs and from what I picked up from the Symposium:
  • The process is still evolving, and therefore, the feedback received from the regulatory authorities on each RMP may vary depending on who reviews the RMP. So, content that was acceptable in one RMP, may be queried in another.
  • The RMP template is under review and needs to be simplified.
  • Part VI, the public summary, is also under review and may be updated to appeal more to a professional audience since patients are more likely to access relevant information about a medicine from European Public Assessment Reports (EPARs) and package leaflets. As a writer, this is good news since there are some inconsistencies in this section, notably the requirement for lay language yet the titles include one about 'epidemiology' which is not a widely used word in everyday speaking.
  • Local RMPs may be required for a particular product if there are country variations in the information required to be included. This makes version tracking, especially when updating the information, particularly challenging.
  • As writers, all we can do is ensure we follow the template and guidance, present the information clearly and succinctly, use correct and consistent grammar, spelling and formats and check the quality before submitting.
Kathryn White is owner and director of Cathean Ltd Medical and Copy Writing Services. She is a published medical, copy and equestrian writer with a passion for creating compelling text in collaboration with her clients. Her customers include pharmaceutical, healthcare and equestrian businesses across the world.