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Consolidated data analysis and presentation using an open-source add-in for the Microsoft Excel® spreadsheet software - Volume 23, Issue

A free and open-source software tool is presented that facilitates the analysis and the visualisation of data in basic life science. Daniel's XL Toolbox is an add-in for the Microsoft Excel® spreadsheet software. It enables scientists to store…

Anonymisation reports from 2016 to 2017: A preliminary analysis - Volume 27, Issue

The anonymisation report (AR) is a new and  relatively unknown regulatory document,  submitted as part of the redacted package of  a marketing authorisation application under  the EMA Policy 0070. The report documents  the methodology of…

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…

Study design made easy - Volume 25, Issue

Analysis of statistical data is an important part of any medical writer’s skill set, especially those professionals working in publication and regulatory areas. Under - standing the various study designs is key to a thorough understanding of study…

Profile: An interview with Ingrid Edsman on why attending EMWA conferences is so rewarding! - Volume 24, Issue

Ingrid Edsman, with 17 years of increasingly senior clinical research positions in the Pharmaceutical Industry, is an expert in the preparation of regulatory and clinical documents. She obtained a Medical Degree at the Karolinska Institute in…

Identifying appropriate journals in which to publish original research on vaccines against human infectious diseases - Volume 21, Issue

The most effective way of communicating new research findings is by publishing them in a peer-reviewed journal which is widely read and highly respected. To ensure that important new data are shared with the appropriate audience in a timely manner,…

Manuscript Writing - Volume 22, Issue

As a medical writer, can or should I be listed as an author of an article? For manuscripts, medical writers often go far beyond providing basic services and therefore may feel entitled to authorship. Medical writers are often the main force behind…

Regulatory Writing - Volume 21, Issue

The discussion section of a clinical study report The discussion section of a clinical study report (CSR) is often a source of doubt among medical writers. The advice is usually to keep the discussion section as short as possible and not go…

Journal Watch - Volume 26, Issue

Data sharing is encouraged by institutions and journals: Authorship of “shared” papers should be clearWhen researchers share data, the teams analysing them want to publish their results. How should authorship of publications be defined? Who are the…

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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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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  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

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