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A medical writer’s perspective on the relationship between EMA Policy 0070 and the General Data Protection Regulation
The EU regulatory system is undergoing a major overhaul. Several new pieces of legislation are now in place to enforce harmonisation and transparency in clinical trials while ensuring data security and individual privacy. New and aspiring medical…
In recent years, regulators across the globe have improved the way they communicate to patients and the general public about their activities and how medicines are regulated.
The financial relationships between the pharmaceutical and device industries and healthcare practitioners appear frequently in the spotlight because of their potential to create bias and influence prescribing choices. Public disclosure of these…
One of the most challenging questions faced by academic life scientists at some point in their career is whether to pursue research or to look for suitable positions within industry. While the shift from academia to industry might result from a…
When several contributors are working on the same document, challenges are often created for both managers and contributors. This article discusses how technology can be used to help produce documents in collaboration.
Have you been commissioned to write a review? Reviews are useful for drawing attention to issues and benefits related to a product. One thing they are not, however, is something to be feared, if you are organised and have a clear idea from the…
The first thing we must say is a huge “thank you” to Dr Juan Garcia Burgos and Mr Paul Blake for taking the time in an unprecedentedly manic year for the EMA to write a foreword for this issue of Medical Writing. The fact that they have prioritised…
We are living at a time when the general public is increasingly interested in scientific and medical advances. Medical journalism is therefore becoming more important to medical writers, although it is a subject that few of us are familiar with. To…
The early benefit assessment of new drugs was introduced in Germany in 2011. The main rationale was to support pricing negotiations between the statutory health insurance (SHI) system and the pharmaceutical industry. The early benefit assessment…
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.
Medical Writing is listed in the following indexes:
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Victoria White
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