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The prerequisite for obtaining marketing authorisation is an appropriate and robust data package that demonstrates a medicinal product’s quality and its efficacy and safety in the proposed indication. Pharmaceutical companies can face regulatory…
Health authority briefing documents (also known as briefing packs, briefing packages, and briefing books) are documents prepared by a pharmaceutical company to support its interactions (e.g. pre-submission meetings, requests for scientific advice,…
Effective learning and development tools are important in spreading and consolidating knowledge within any pharmaceutical or biotechnology company. Medical communications professionals may be involved in creating training materials for many…
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,…
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…
Nonclinical evaluation is a key component of drug development. Traditionally, scientists have prepared much of the written regulatory documentation, with dedicated nonclinical writing being a niche profession. This is changing – the demand for…
One measure of career success for clinical researchers is reporting their findings in a peer-reviewed journal. Writing a clinical manuscript that has impact and relevance to their intended audience is crucial for publication success. However,…
Many PhDs and postdocs in academia realise that they do not have such a strong passion for the bench, so some dream of becoming medical writers, but they often lack the information, training, connections, experience, and (most importantly)…
I know all the stereotypes about vets. We work as clinicians as seen in All Creatures Great and Small and are intrinsically motivated to help every animal we cross. And yes, that is partly true. There are three major pillars in which vets can work.…
Research on psychotropics is gaining more popularity worldwide and support from drug regulatory agencies, which recognise the unmet medical needs of certain patient communities, such as patients with mental disorders and patients with cancer who…
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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