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At the conference dinner in Manchester this year, the creation of two very special scholarships was announced. The scholarships are in memory of one of the founding fathers of EMWA, Geoff Hall, who sadly passed away in 2010. Geoff was not only a…
Informed consent forms (ICFs) are documents used in clinical research to inform prospective participants about – and obtain their consent for – partaking in a clinical trial. Evidence suggests that ICFs may not be fit for purpose because their…
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…
In April this year, the World Health Organisation (WHO) issued a statement on the public disclosure of clinical trial results (the full statement is available from http://www.who.int/ictrp/results/reporting/en/). In essence, this statement…
We have three articles in this edition. Pamela Haendler's contribution deals with the medical writer as a reviewer and quality checker. Because of their close involvement with all of the documentation on a project, the medical writers involved are…
In 2004, health technology assessment (HTA) was recognised as a ‘political priority’ by the EC and Council of Ministers, which led to a call to establish an effective and sustainable European network for HTA (EUnetHTA). The result was the…
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…
In this issue, we are bringing to you many updates on different aspects relevant to our medical writing community. Tim Koder from Oxford PharmaGenesis introduces the Open Pharma project, which aims to promote and aid a faster and more transparent…
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…
Dear colleagues Time really does fly when you're having fun: I'm writing my third message since becoming EMWA President in May! The 37th EMWA Conference in Barcelona was an exciting event in a great location. We welcomed 102 new members, and 240…
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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