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Graphing software for medical writers - Volume 23, Issue

The production of high-quality graphical figures of scientific data is an important aspect of medical writing, since the significance of the research findings can be lost to the audience if the data are presented poorly or inaccurately. This…

Challenges of working from home during the COVID-19 pandemic: A survey to inform working practices - Volume 30, Issue

In response to the COVID-19 pandemic working practices changed for members of the medical communication community. We devised a multifactorial online survey to better understand the impact of these changes. Of the 759 respondents, 85% had a positive…

News from the EMA - Volume 30, Issue

First CAR-T cell medicine for mantle cell lymphoma October 16, 2020 – The EMA has recommended granting a conditional marketing authorisation in the EU for Tecartus (autologous anti-CD19-transduced CD3+ cells) for the treatment of adult patients…

Publication management software for medical writers - Volume 29, Issue

Managing a complex publication plan for several products or indications with overlapping timelines can be challenging. Publication management software solutions are available to support the medical writer in planning, writing, approving, and…

Medicines information for patients: Insights into research and practice for medical writers - Volume 21, Issue

Many people do not take their medicines as prescribed, and medicines can cause harm if not used appropriately. In addition, in most health systems there is increasing discussion about involving patients in decisions about their health – including…

Non-interventional Post-Authorisation Safety Studies (NI-PASS): A different type of report - Volume 23, Issue

Although Post-Authorisation Safety Studies (PASS) have been around since 2001, most regulatory writers would have been unaware of their existence until the recent changes in European regulations, which include mention of these studies as part of…

EMWA’s newest special interest group: Sustainability SIG - Volume 29, Issue

In 2015, the United Nations set 17 Sustainable Developments Goals (SDGs, Figure 1) as a “universal call to action to end poverty, protect the planet, and ensure that all people enjoy peace and prosperity by 2030”.1 Central to these SDGs is planetary…

Layperson materials in the sphere of biosimilars and generic medicines - Volume 28, Issue

Generics and biosimilars offer effective treatment alternatives to branded reference drugs at a lower cost. Despite their widespread use, patients have mis conceptions regarding their efficacy and safety. Layperson materials offer an important means…

Pharmacovigilance for vaccines and immunotherapies - Volume 27, Issue

Although the content of EU Periodic Benefit- Risk Evaluation Reports (PBRERs) for vaccines is governed by the same regulatory framework as applies to other medicinal products, the complex nature of vaccines presents vaccine-specific challenges that…

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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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