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Profile: An interview with Professor Peter Jüni on methodology and statistics in scientific manuscripts - Volume 25, Issue

This issue of Medical Writing (MEW) is about statistics, so what is more appropriate than interviewing a research methodologist who focuses on epidemiology and statistics in clinical research? I am happy that we were able to win Professor Peter Jüni…

Pharmaceutical writer or CRO writer – choosing the right path - Volume 28, Issue

The career choice is an unavoidable topic for those scientific graduates or experienced professionals in the areas of medicines or the pharmaceutical industry. The career of medical writing offers a series of career possibilities for the individuals…

Enhancing accessibility of study data: The development of a graphical abstract for lay summaries of clinical trial results - Volume 29, Issue

We describe the development of a graphical abstract for lay summaries of clinical trial results. The new graphical summary serves the same purpose for a lay summary as an abstract does for a scientific publication. Lay summaries are intended to…

The freelance medical writer and the medical writing agency: A symbiotic relationship - Volume 32, Issue

The medical writing industry is evolving. With a growing demand for competent and experienced medical writers in both the product industry (pharmaceutical, biotechnology-related, and medical technology-related) and service providers (clinical…

Out On Our Own - Volume 22, Issue

We are all riding high after meeting in Manchester at the EMWA conference in May 2013. It was wonderful to see so many colleagues coming together and enjoying the new-look events that EMWA offered us for the first time. Both the Symposium Day, and Ka…

Regulatory pathways for development and submission activities - Volume 28, Issue

This article discusses how different regulatory requirements for a dossier requesting marketing authorisation for a medical drug affect the deliverables from development functions and the submission groups including medical writing. The content of…

Using social media as the patient's voice in the benefit-risk assessment of drugs: Are we ready? - Volume 24, Issue

There is no doubt that the public interest in healthcare-related issues is growing. This, coupled with the surge in the use of social media, leaves the pharmaceutical industry with a set of unique opportunities and challenges. The screening and…

Risk management plans in the EU: Managing safety concerns - Volume 29, Issue

The preparation of pharmacovigilance documents is related to ongoing activities during the life cycle of a medicinal product and encompasses crucial processes beyond writing: strategic planning and inter disciplinary work in the context of…

Scientific advice procedures in the EU – an overview ofthe regulatory background - Volume 29, Issue

The prerequisite for obtaining marketing authorisation is an appropriate and robust data package that demonstrates a medicinal product’s quality and its efficacy and safety in the proposed indication. Pharmaceutical companies can face regulatory…

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…

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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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