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Medical writing in India at a crossroads - Volume 22, Issue

Pharmaceutical regulatory medical writing for document submissions to Western health regulatory agencies has been undertaken in India for almost 10 years. From humble beginnings in a couple of non-Indian pharmaceutical multinational giants –…

Medical writing for generics throughout the life cycle - Volume 28, Issue

Medical writing plays an integral part in the pharmaceutical industry, be it for originator or generic drug companies. Most writers are working for medium to large research-based companies. However, even for generic drug firms many documents need to…

Journal Watch - Volume 21, Issue

Readability of informed consent forms, sponsor participation in industry trials, and conflict of interest disclosure. Informed consent is a crucial feature of clinical research trials. Guidelines on developing an informed consent form urge writers…

Challenges of paediatric drug development and impact of paediatric legislation - Volume 21, Issue

Medical writers are increasingly involved in designing and documenting overall plans in paediatric drug development, e.g. EU PIPs (Paediatric Investigation Plans) and individual components, e.g. protocols and study reports. It is essential to…

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…

Landscaping the terminology of accessible language document types - Volume 31, Issue

There are three main types of accessible language documents that medical writers and medical publications professionals may work on. These are regulatory lay summaries, publication-associated plain language summaries (PLS), and standalone plain…

Medical Communications - Volume 26, Issue

Dear all,The legal side of our job is something that most of us usually give little thought to. We assume that as scientists, we are automatically on the “right side” and therefore pretty bulletproof. Why should the law affect us, as longas we have…

Writing for patients: When and how? - Volume 29, Issue

The move towards patient engagement and patient involvement in healthcare decisions (“shared care”) has triggered a raft of new guidances from regulatory authorities, accompanied by new regulations mandating that pharmaceutical companies engage with…

An introduction to medical affairs for medical writers - Volume 28, Issue

The role of medical affairs in pharmaceutical and medical device companies is gaining prominence. Medical writers will increasingly find themselves supporting medical affairs activities or, indeed, transitioning to jobs within medical affairs…

Journal Watch - Volume 21, Issue

Improving the credibility of reporting industry-sponsored research Reports of ghostwriting, guest authorship, selective or biased disclosure of research results, and inaccurate or incomplete reporting of potential conflicts of interest have damaged…

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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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