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From scurvy to Covid-19: The role of clinical trials, and medical writing’s crucial role in the process The medical writing community is intrinsically involved in regulatory documentation that spans the entire timeline of clinical research – from…
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…
A year of EMWA firsts has passed and while we are still not in a post-pandemic phase, one can see that our profession has regained its momentum. In the past, you might have experienced the need to explain to family members and friends what “medical…
The reach and impact of social media have made this communication channel the latest in a number of multidimensional communi - cation tools to be employed in health research. Social media has become a com - muni cation tool to reach various…
Adoption of the EU Medical Devices Regulations and In Vitro Diagnostics Regulations has led to increased demand for systematic literature reviews. This article reports on a survey investigating the current use of software platforms and tools by…
News from the EMWA Website Manager New role At the recent EMWA conference held in Cyprus, I assumed the position of EMWA Website Manager. While this is a daunting task, it is a challenge I am pleased to take on. To ensure that I was in a…
A medical writer has a unique opportunity to be involved with documents across the various stages of a product’s lifecycle. At the start of their careers, writers typically specialise in documents that are created in a particular phase of drug…
Spotlight on similar devices under the Medical Device Regulation This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market…
Applications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to…
Ruggero Galici is Senior Director of Nonclinical and Clinical Pharmacology Medical Writing at Alexion Pharmaceuticals Inc, AstraZeneca Rare Disease Unit and heads up global early phase regulatory medical writing activities. In this role, he…
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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