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Introducing EMWA’s new AI Working Group - Volume 32, Issue

Artificial Intelligence (AI) is a broad umbrella term that refers to the use of computer algorithms to perform tasks that typically require human-like intelligence, such as reasoning, learning, decision-making, and perception. The new EMWA AI…

European network for health technology assessment – EUnetHTA - Volume 22, Issue

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…

Message from the President - Volume 22, Issue

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…

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…

Overcoming confidential information challenges faced by study sponsors today - Volume 32, Issue

As health authorities aim to increase clinical trial transparency and visibility to the public, pharmaceutical manufacturers are facing new pressure points. New regulations require the disclosure of clinical trial application data, many of which cont…

Statistical principles in biosimilar development - Volume 28, Issue

Unlike new drug development where superiority over an active comparator or placebo often has to be proven, biosimilar development focuses on showing similarity of the proposed biosimilar to an already approved reference product. This affects…

Organising the review process in Microsoft Word® - Volume 23, Issue

Regulatory documents are prepared in a highly collaborative process within tight timelines. The time and the resources required for collecting input, organising document review, and processing the reviewers’ responses often dwarf those invested in…

Announcing the Geoff Hall Memorial Scholarships - Volume 22, Issue

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…

Regulatory Writing: New developments in public disclosure of clinical trials - Volume 24, Issue

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…

Results of the 2016 EMWA member survey - Volume 26, Issue

In October 2016, EMWA’s Executive Committee sent an on-line survey to all EMWA members. The purpose of the survey was to obtain more information about our members, what they do, and what they want from the organisation. 286 responses were received.…

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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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