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The initial requirements of clinical trial disclosure were to register a clinical trial to make it publicly accessible to patients and thereby making the enrolment into a clinical trial easier. In the meantime, the disclosure ofclinical trials in…
Today, the principles of good clinical practice (GCP) form such an integral part of the development of new medicines that they could easily be taken for granted. Yet, the road to a universal code of ethics in human experimentation is paved with…
Introducing a new EMWA Special Interest Group: Communicating with the Public Contributors: Sampoorna Rappaz (author), Lisa Chamberlain James (section editor) The Communicating with the Public Special Interest Group (CwP SIG) held its first Meet…
It’s been more than 6 years since our last Medical Writing edition dedicated to clinical trial transparency and disclosure. Since then, we have seen the full implementation of the long-awaited EU Clinical Trials Regulation (CTR), the pause and restar…
NCBI´s PubMed is a powerful literature retrieval tool widely utilised in many areas including science and regulatory affairs. In regulatory affairs, PubMed searches are employed to identify clinical evidence pertinent to product approval…
We medical writers have a unique and valuable skill set, which includes, most notably, the ability to understand and clearly communicate complex medical information. We are also experts at working with multifunctional teams, compiling detailed…
Dear EMWA Members, It is my very great pleasure to ‘speak’ to you from the pages of the very first issue of Medical Writing of 2016, with our new printer, Hastings. I am particularly excited that our feature articles are now open-access – a…
This story may sound familiar. Having spent my entire career on the academic bench, I decided it was time for a change. I still want to use my brain, I still want to be a part of the biomedical sciences, but I am ready to put the pipette down for…
For most of us, medical writing is highly technical. We prepare regulatory or clinical documents or write materials targeted to medical doctors. Medical writing for lay audiences is different, and it does not come naturally to most of us because…
Plain language is writing in clear, concise language that is easy to read and understand. Whenever I hear the term plain language I am reminded of a lay summary I was once asked to edit. The stream of technical language (‘self-source bias’, ‘effect m…
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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