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Medical Devices - Volume 28, Issue

Digital health is touching many aspects of the medical device world. Here Beatrix Doerr provides her perspective on the ways digital health and artificial intelligence have touched the medical device world and have already changed the way healthcare…

Out on Our Own - Volume 28, Issue

Surprisingly, many professionals still don’t fully appreciate how professional associations can help them in their career path. They may view associations as training grounds in a given field and forget or disregard all the other opportunities these…

Mentor vs. line manager: Differences and similarities - Volume 30, Issue

A good mentor may be a good line manager in a business setting and vice versa, but there are some key differences: mentors are more skill-oriented, while line managers are more goal-oriented. People who are both good line managers and mentors are…

HIV vaccine clinical trials: An overview - Volume 27, Issue

More than 30 years after the discovery of the human immunodeficiency virus as the agent that causes AIDS, an effective vaccine against this deadly disease has yet to be developed. The pathway to the development of a vaccine has been riddled with…

1000 words in 1 picture - Volume 28, Issue

Communication is as much verbal as it is visual. We tend to rely on technical texts for transmitting medical information, but sometimes an image may convey complex medical concepts in a simpler and shorter form. Medical illustration requires…

Scientific advice procedures in the EU – an overview ofthe regulatory background - Volume 29, Issue

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…

The value of registry data in the clinical evaluation of medical devices - Volume 29, Issue

Medical device manufacturers must continuously evaluate all clinical data available for their products marketed in Europe. With the European Medical Device Regulation 2017/745 coming into force in May 2021, manufacturers are required to assess…

Software for translators - Volume 23, Issue

In recent years, a myriad of software has revolutionised the translation sector. This article presents a series of translation tools commonly used in the translation industry, depicting their main features and the way they have transformed the…

Non-interventional Post-Authorisation Safety Studies (NI-PASS): A different type of report - Volume 23, Issue

Although Post-Authorisation Safety Studies (PASS) have been around since 2001, most regulatory writers would have been unaware of their existence until the recent changes in European regulations, which include mention of these studies as part of…

The MHRA perspective on the new pharmacovigilance legislation - Volume 21, Issue

Following an extensive period of drafting, consultation, negotiation, and re-drafting the new European Legislation came into effect in July this year. The new measures will be the biggest change to medicines legislation since the creation of the…

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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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