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Localisation of promotional materials for pharma - Volume 33, Issue

Unwarranted changes by the client, lengthy approvals, and multiple rounds of revision – localisation of promotional materials for pharmaceutical companies can become a nightmare if the localisation specialist is unaware of heavy regulations in the…

Are stem cells the future of healthcare? - Volume 21, Issue

Stem cell technology holds a key, although arguably not an exclusive position, in the future of healthcare. Alongside two other candidates worthy of this mantle – personalized cancer medicine and vaccine development – all three healthcare…

Global HTA: Past, present, and future - Volume 30, Issue

Health technology assessment (HTA) is a relatively recent innovation that has changed the way decisions are made in healthcare. It is a multidisciplinary process that requires different skill sets and collaboration among various disciplines and…

Implications of clinical trial data sharing for medical writers - Volume 22, Issue

Major clinical research funders are increasingly adopting policies supporting or mandating data sharing. These moves should improve the transparency and availability of clinical trial data and are likely to impact the work and responsibilities of…

Editorial - Volume 27, Issue

A paradigm shift in clinical trial data reporting is occurring as data becomes increasingly publically accessible. The EMA was the first regulatory authority to publish clinical data included in marketing authorisation applications.

Package leaflets for medication in the EU: The possibility of integrating patients’ perspectives in a regulated genre? - Volume 24, Issue

Package leaflets (PLs) have been legally required to accompany medicines in the EU since 1999. Despite the best intentions and efforts, however, they are generally not well-received by the public for whom they are intended. This paper picks up on…

Regulatory Matters & Regulatory Public Disclosure - Volume 27, Issue

A symbiotic relationship is an “intimate interaction between two or more species, which may or may not be beneficial to either”.1We can think of the bee and flower relationship. The flower provides the bee with nectar, while the bee provides…

EMWA News - Volume 25, Issue

EMWA team responds to ICMJE requirements on sharing clinical trial data In January 2016, the International Committee of Medical Journal Editors (ICMJE) proposed requirements on sharing clinical trial data, in Darren Taichman’s editorial, Annals of…

Regulatory Matters - Volume 26, Issue

Medical writers are often involved in the preparation of submission documents such as clinical overviews and clinical summaries. The submission of the application (or, in the case of drugs already approved, a variation or supplement) is an important…

Transition to the EU Clinical Trials Regulation: Trick or treat? - Volume 32, Issue

The etiquette in clinical trial research requires companies to respect rules and to be precise and accurate. The new EU Clinical Trials Regulation 536/2014 (EU CTR) pushes companies and health authorities one step further – to be more flexible 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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