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Pleasing the reader by pleasing the eye—Part 2 Page layout and readability - Volume 22, Issue

The purpose of page layout is to consciously arrange text and graphics on a page in a way that supports the reading process and allows the reader to effortlessly follow the flow of information. It should blend words and images into an effective…

Regulatory writing - Volume 21, Issue

The EMA, the FDA, and Health Canada head to head A recent issue of the New England Journal of Medicine carried an article comparing the regulatory review times of novel therapeutics by three different regulatory agencies (FDA, EMA, and Health…

Gained in Translation - Volume 26, Issue

Medical translation training around Europe It’s been said a thousand times, yet, many are still not fully aware of the importance that translation has in our daily lives. Rather than merely supplanting one form of words with another, the translator…

Living medicine: The story of CAR T cell therapy - Volume 32, Issue

The advent of chimeric antigen receptor (CAR) T cell therapies follows a decades-long quest to personalise the treatment of disease. This article highlights the early research that paved the way for the field today, touching on early pioneers in the…

Building resilience: Navigating challenges and thriving among the demands of regulatory writing - Volume 33, Issue

Regulatory writing is a demanding yet rewarding profession in which writers help pave the way for groundbreaking healthcare innovations that improve the lives of patients. However, as critical as our work is, regulatory writing is full of challenges…

The work model of hybrid freelancing - Volume 32, Issue

Must we choose between a path as a self-employed, freelance medical writer, or as an in-house employee? It might come as a surprise that a medical writer can enjoy both worlds. If you dream of becoming a freelance medical writer but dread losing…

Writing for pharmaceutical or medical device companies: A survey of entry requirements, career paths, quality of life, and personal observations - Volume 25, Issue

The spectrum of medical writing activities across the pharmaceutical and device industries is vast. We conducted a limited survey of medical writers predominantly working in industry or for agencies to learn of their personal and professional…

The approval process of medicines in Europe - Volume 23, Issue

The European system of approval of new medicines comprises an European Union (EU)-wide authorisation procedure (the so called centralised procedure) alongside national procedures based on different EU Member States working together and recognising…

Beyond limits – Leading at the Edge - Volume 30, Issue

Every member of a working group or a team has a defined role, such as that of a leader or a mentor. Although every role has its own distinct definition, a great mentor can be a great leader and vice versa. One of the finest mentor leaders, explorer…

The periodic safety update report and post market surveillance report under the new EU Medical Device Regulation - Volume 31, Issue

The new EU Medical Device Regulation 2017/745 (MDR) requires companies to provide a periodic safety update report (PSUR) and a post market surveillance report (PMSR). Creating these reports will strengthen the post market surveillance and vigilance…

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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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