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The Clinical Trials Regulation (EU) No 536/2014 (CTR) came in force on January 31, 2022, specifying requirements for performing clinical trials in the EU and the European Economic Area (EEA). The CTR and the Clinical Trials Information System (CTIS)…
The clinical research landscape is constantly evolving, as new regulations and innovations come together to help accelerate scientific discoveries and medical advances. A prominent example of this is the rapidly emerging technology of artificial…
In this release of My First Medical Writing, I have the pleasure to share great articles written by two aspiring medical writers. Nesrine Benhizia-Benaouicha, MD, is a clinical trial manager and academic medical writer at the emergency department in…
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…
In this release of My First Medical Writing, we welcome one of the first articles written by Robin Sachdeva. Robin finished his PhD at Heidelberg University in Germany, and he is passionate about reading and writing about diabetes. Fortunately,…
Although medical writing as a career has been around for a few decades, medical writing education is relatively new. Many medical writers end up teaching scientific or medical writing, and have built their courses and their teaching style without…
Like many medical writers, I started in another career first. For me, it was practising veterinary medicine in a clinic, then going into clinical research in humans, and then on to medical writing. Designing clinical trials, sample size…
As many of you are already familiar, Medical Writing began as The Write Stuff, a publication written by and for EMWA members. One of the goals in making the transition to Medical Writing was that it would become an international journal with readers…
Dear All, In this edition of Medical Writing, I’m delighted to present an article from Vidhi Vashisht and colleagues on a subject very close to my heart – plain language summaries (PLSs). PLSs are summaries of clinical trial results written in a…
Uri Kartoun (PhD in robotics, Ben Gurion University of the Negev, Israel) is a Staff Research Scientist and an IBM Master Inventor, co-developer of technologies such as MELD-Plus, EMRBots, Memory-memory (M2) Authentication, and Subpopulation-based…
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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