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Writing Lay Language Summaries of Study Results according to EU Regulation

Medical Communication
Workshop profile:
This workshop is for medical writers who want to engage in the writing of lay summaries of study results as mandated by the EU regulation. Participants should already have an understanding of CSR structure (ICH E3) and should know the basics of clinical research (trial design, efficacy and safety analysis, basic statistics).
Writing lay summaries is a difficult and challenging task. Medical writers with an interest in lay writing are well suited for this new and upcoming activity. However, the provision of lay summaries requires a lot more than good lay language writing. The workshop will introduce the many different aspects of providing lay summaries: the available regulatory guidance, the positions of various stake holders (pharma and patient organisations), the intricacies of the actual writing of lay summaries, and considerations for appropriate distribution of the lay summaries.
The workshop will introduce the requirements for lay language summaries of study results according to the EU regulation. The various guidance documents from stakeholders (HRA, TransCelerate, MRCT, European Commission) will be reviewed, appraised, and discussed. The content requirements for lay summary will be presented and possible solutions will be discussed. As lay language writing is difficult and complex, only the basic principles of plain language writing will be covered. To appreciate the complexity of lay language writing in a confined context, the workshop will have a practical exercise as participants will be asked to write a short paragraph of a lay summary. In addition the various distribution options for lay summaries and the issue of translations will be discussed.