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The healthcare industry has witnessed a significant shift towards the use of real-world data (RWD) and real-world evidence (RWE) in medical decision-making and treatment evaluation. This article explores the importance of RWE in healthcare…
If economic evaluations are to be used by researchers and healthcare decision makers, they need to be adequately reported. This article discusses the update of the Consolidated Health Economic Evaluation Reporting Standards (CHEERS 2022), the main…
Before one can get one’s foot in the door, one needs to be aware that there is actually a doorway. This is the mission of the EMWA Ambassador’s Programme – to inform the world about medical writing as a career path. In other words, we set up signs…
A useful reference for writing pharmacovigilance documents Like other areas of medical writing, pharmacovigilance (PV) medical writing has many detailed regulations, guidance documents, and templates associated with it. As such, there is a…
The Sustainability Special Interest Group (SUS-SIG) of EMWA was established in 2020 to support the United Nations 2030 agenda for sustainable development from the perspective of a not-for-profit professional organisation for medical writers and…
Anuradha Alahari (section editor) EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo OPEN framework extended to a wider range of medicines Global regulators agree on way forward to adapt COVID-19 vaccines to…
Current practice requires clinical and regulatory documents to be created and updated manually by medical writers throughout a product’s development. Conventionally, document content is unstructured, with freeform text, figures, and tables that the…
Publishing Your Medical Research (Second Edition)Daniel W. ByrneWolters Kluwer, 2017Daniel Byrne has taught courses on biostatistics and medical writing at Vanderbilt University since 1999. He wrote the first edition of Publishing Your Medical…
This section offers a selection from recent news items from the EMA. Medical Writing. 2023;32(2)86–91.
As the EMA refines its requirements for the external publishing of clinical study reports, the workload of medical writing teams is increasing to include robust processes for clinical study report anonymisation. Until now, life sciences firms have…
Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.
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