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Message from the President - Volume 21, Issue

Dear Members I am sure you are all very familiar with this situation – sitting in front of a blank piece of paper (or to be more accurate a blank screen) and wondering where to start. Beginnings and endings always seem to be the trickiest part, but…

The In Vitro Diagnosgtics Regulation and the role of medicals writers - Volume 29, Issue

Even though in vitro diagnostic medical devices (IVDs) occupy only a very small market segment in the healthcare sector, they have a vital role to play. The importance of diagnostics was strongly underlined during the COVID-19 pandemic. In the EU,…

Guidance for the design and analysis of observational studies: The STRengthening Analytical Thinking for Observational Studies (STRATOS) initiative - Volume 26, Issue

Observational studies pose a number of biostatistical challenges. Methodological approaches have grown exponentially, but most are rarely applied in the real world. The STRengthening Analytical Thinking for Observational Studies (STRATOS) initiative…

European network for health technology assessment – EUnetHTA - Volume 22, Issue

In 2004, health technology assessment (HTA) was recognised as a ‘political priority’ by the EC and Council of Ministers, which led to a call to establish an effective and sustainable European network for HTA (EUnetHTA). The result was the…

Good Writing Practice - Volume 32, Issue

Author: Michael Lewis Schneir Section Editors: Wendy Kingdom, Amy Whereat Syntactic punctuation distraction Comma: Over-usage Part 2 Coordinated noncore sentence constituents are likely to be disrupted by unnecessary comma punctuation. Medical…

Good clinical practice (GCP): A universal call for ethics in biomedical research - Volume 23, Issue

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…

Awareness of medical writing as a profession and its career prospects - Volume 27, Issue

As medical writing (MW) is a growing profession in India, we assessed the awareness among professional medical writers (PMWs) about their job and career prospects. We conducted an anonymous survey among PMWs (N=192) working in a global…

Outgoing President’s Message - Volume 32, Issue

Over the finish line The remarkable success of EMWA’s 55th conference, held in Prague, seems as the perfect culmination of my one-year service as the EMWA president. Medical Writing. 2023;32(2)5. https://doi.org/10.56012/mnre9850

Regulatory pathways for development and submission activities - Volume 28, Issue

This article discusses how different regulatory requirements for a dossier requesting marketing authorisation for a medical drug affect the deliverables from development functions and the submission groups including medical writing. The content of…

New EU medical device regulations: Impact on the MedTech sector - Volume 26, Issue

Abstract Regulation plays a fundamental role in the translation of innovative medical devices from concept to clinical application and ensures that only devices that exhibit the highest standards of safety and quality are released onto the EU Single…

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Scope

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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