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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…

Biosimilars: Change, challenge, and accomplishments - Volume 28, Issue

Since the first biosimilar product was approved in Europe in 2006, there have been many developments in the global regulatory environment, and the healthcare community’s understanding and acceptance of biosimilars. However, there are still a number…

Out on Our Own - Volume 26, Issue

As a part of its initiative in forging alliances with associations that promote freelancing at a national level in Europe, EMWA has recently tied up with the Verband der Gründer und Selbständigen Deutschland e.V. (VGSD) which is based in Germany.…

Psychotropics: A scientific, regulatory, and public view on the medicinal uses of cannabinoids and psilocybin - Volume 32, Issue

Research on psychotropics is gaining more popularity worldwide and support from drug regulatory agencies, which recognise the unmet medical needs of certain patient communities, such as patients with mental disorders and patients with cancer who…

Lessons from building an accredited medical conference: Design and delivery - Volume 25, Issue

Participation in meetings and events by healthcare professionals is part of their continuing professional development, and it is a requirement for organisers to gain accreditation for continuing professional development in order to attract…

An overview of the Common Technical Document (CTD) regulatory dossier - Volume 23, Issue

The Common Technical Document (CTD) was designed to provide a common format between Europe, USA, and Japan for the technical documentation included in an application for the registration of a human pharmaceutical product. The CTD dossier is divided…

Fifth EMWA freelance business survey - Volume 25, Issue

Following surveys in 2003, 2007, 2010 and 2012, the fifth EMWA Freelance Business Survey was conducted in 2015. 181 respondents, most based in Europe, completed the survey. The findings indicate that freelance medical writing and related activities…

A rising tide: Hospitals and social media - Volume 21, Issue

The advent of social media has changed the face of healthcare communications. More and more hospitals are recognizing this fact and seeking to integrate tools like Twitter® and Facebook® into their own communications strategies. This article gives…

Regulatory Writing Developments in paediatric regulation - Volume 22, Issue

Recently, both sides of the Atlantic have seen developments in paediatric regulation. In Europe, the EMA has published a new template for the paediatric investigation plan (PIP), which should help dispel some (but by no means all) doubts and…

Out On Our Own - Volume 22, Issue

The fourth EMWA freelance business survey Introduction This fourth survey follows those conducted in 2003, 2007, and 2010.1–3 The first survey was conducted with a paper questionnaire distributed to both freelancers and small businesses…

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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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