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Medical Communications - Volume 26, Issue

Dear all,The legal side of our job is something that most of us usually give little thought to. We assume that as scientists, we are automatically on the “right side” and therefore pretty bulletproof. Why should the law affect us, as longas we have…

Medical Communications - Volume 26, Issue

Well here’s a sentence I never thought I’d write: In this issue we learn how the Argentine Tango can make us better writers. Really! When our contributor, Susanne Geercken, told me that this was the topic she’d chosen, I was both intrigued and…

Anonymisation: A new challenge for medical writers - Volume 27, Issue

In its commitment to transparency, the EMA implemented Policy/0043 and Policy/0070 to make data accessible to all; however, this has given rise to the need for anonymisation of personal data in clinical reports. The analysis of the 64 submission…

Recent and upcoming regulatory changes in the European Region: Opportunitiess for medical writers - Volume 29, Issue

The European regulatory landscape for clinical trials and medical devices is in the midst of major transformation. Older policies are giving way to new regulations that emphasise more harmonised and streamlined processes for document submittal,…

What medical writers need to know about regulatory approval of mobile health and digital healthcare devices - Volume 28, Issue

The rapid growth of mobile health (mHealth) led to the development of internationally harmonised guidance for software as a medical device (SaMD) by the International Medical Device Regulators Forum (IMDRF), covering definitions, risk…

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…

A medical writer's must-have software - Volume 23, Issue

This article provides a list of software useful to medical writers according to the booklet ‘The WRITE tool for the job’ compiled by Emma Hitt. Software categories include: word processors; reference managers; PDF readers; project planning and…

Best friends forever: A pattern of collaboration between medical writers and biostatisticians within the Russian CRO - Volume 25, Issue

The Russian clinical trial industry and Russia’s local regulatory requirements are developing rapidly. Within Russian contract research organisations, medical writers must take on non-traditional roles and, in particular, must collaborate closely…

How the EU Medical Device Regulation is affecting the medical device landscape. An interview with Suzanne Halliday, the Regulatory Head of BSI, Medical Devices Notified Body - Volume 31, Issue

Suzanne Halliday, D.Phil., is the Vice President for Regulatory within the Notified Body BSI with extensive experience in compliance to the Medical Devices Directive (MDD), ISO 13485, risk management, clinical evaluations and investigations, meeting…

Sound, microphone, action: Podcasts for medical writers - Volume 28, Issue

A podcast is a digital audio file that can be downloaded into your computer or mobile device. It is typically available as a series, and new episodes can be received automatically by subscribers. Podcasts are a source ofeducation, inspiration, and…

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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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