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The perils of the unknown: Missing data in clinical studies - Volume 27, Issue

The phenomenon of missing data is ubiquitous in clinical studies. Both the extent of missing data and the structure of missing data can introduce bias into study results and lead to wrong conclusions. Medical writers should be aware of the extent of…

Medical Communications and Writing for Patients - Volume 33, Issue

Section Editor: Lisa Chamberlain James Encouraging vaccination through clever and abstruse incentives Author: Yannick Borkens The COVID-19 pandemic kept the world on tenterhooks for several years beginning in 2019. Well over 7 million people had…

Cost comparison of salaried and freelance medical writers working in Europe - Volume 23, Issue

This is the first systematic comparison of the costs of salaried and freelance medical writers working in Europe. In the absence of official figures for the total costs of employment, we make reasoned assumptions, using mean base figures for…

President’s Message - Volume 33, Issue

See you in Valencia… Time is flying. We just left the autumn conference and now are approaching our main EMWA event – the spring conference, to take place May 7– 11, 2024. This time we go to Valencia, and I am sure that no one needs to be…

Regulatory Matters - Volume 30, Issue

One key point in 2012 to the Good Pharma - covigilance Practices (GVP) guidelines was mandatory consultation of all stakeholders before the first publication of GVP and after its implementation. Execution of these guidelines was influenced by public…

Profile: An interview with Art Gertel on the Budapest Working Group - Volume 24, Issue

Art Gertel (AG), with nearly 40 years of increasingly senior management level positions in the pharmaceutical industry, is an expert in the preparation of large, complex corporate and regulatory documents and is thoroughly familiar with relevant US,…

Allergen immunotherapy in the European regulatory environment - Volume 27, Issue

Allergen immunotherapy (AIT) modulates the immune system to prevent and relieve allergic symptoms. Unlike allergen avoidance and medication to control symptoms, AIT targets the underlying pathophysiology of allergic diseases. AIT is now considered a…

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…

News from the EMA - Volume 24, Issue

The articles included in this section are a selection from the EMA's news and press release archive for March–June 2015. More information on the work of the EMA can be found on its website: http://www.ema.europa.eu.

Estimands – closing the gap between study design and analysis - Volume 27, Issue

Estimands represent a new way to look at key aspects of clinical research and will become increasingly important for medical writers. Estimands are detailed definitions of quantities to be estimated using clinical trial data, which make allowance…

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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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