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Getting Your Foot in the Door - Volume 30, Issue

Below, two young colleagues share their experiences as mentees and the benefits they gained from such programmes. First, Geneviève Laumen tells it from the perspective of being part of an organised, structured mentorship. Next, Ivana Turek shares…

India as a hub for ethical and evidence-based medical communications - Volume 22, Issue

Ethical and evidence-based medical communications are gaining increasing importance in emerging pharmaceutical markets, outside of North America and Western Europe. In large pharmaceutical companies resources are limited, and small and mid-sized…

Translating medical devices: A rule-driven game - Volume 33, Issue

Translation for medical devices often presents a unique set of challenges arising from the products’ complex natures and associated regulatory requirements. Beyond medical expertise, linguists – from translators and editors to bilingual quality…

Good Writing Practice - Volume 26, Issue

Conceptual component omission is a distraction to a content expert who expects specific argumentative conceptual components in the various sections of a journal article. As evidence, some of the components have become standardised in structured…

Writing reports of modelling and simulation analysis: Our experience in the field of pharmacometrics - Volume 32, Issue

Pharmacometric analyses generate mathematical models that can describe and simulate the pharmacokinetics and pharmacodynamics of drugs. The role of these modelling and simulation (M&S) analyses is growing both in drug development and regulatory…

Early benefit assessment of new drugs in Germany: Framework for submission of dossiers by pharmaceutical companies - Volume 22, Issue

For the early benefit assessment of new drugs in Germany, medical writers are involved in the preparation of dossiers submitted by pharmaceutical companies to the main decision-making body of the German statutory healthcare system, the Federal Joint…

Lessons from building an accredited medical conference: Design and delivery - Volume 25, Issue

Participation in meetings and events by healthcare professionals is part of their continuing professional development, and it is a requirement for organisers to gain accreditation for continuing professional development in order to attract…

The unique challenges of clinical trials in rare disease: A regulatory writer’s perspective - Volume 32, Issue

Designing clinical trials in rare diseases comes with a specific set of challenges including limited knowledge around the natural history of a disease, small sample size available for trial participation, regulatory guidance that is not calibrated…

Biostatistics and medical writing: Synergy in preparing clinical trials documents - Volume 25, Issue

Biostatisticians and medical writers are among the key people who develop important documents for clinical trials. These documents include clinical study protocols, statistical analysis plans, statistical outputs, and clinical study reports. This…

Lingua Franca and Beyond - Volume 25, Issue

Communication, communication and even medical communication What is it about? Let’s start with the Wikipedia definition: “Communication (from Latin comm - ūnicāre, meaning ‘to share’) is the purposeful activity of information exchange between two…

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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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