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Biosimilar development – an overview - Volume 28, Issue

Biosimilars are biological drugs that are similar to, and cheaper than other biological drugs (called “reference originator biologics”) that are already in use. They share an identical amino-acid sequence but, given the inherent variability of…

Overcoming confidential information challenges faced by study sponsors today - Volume 32, Issue

As health authorities aim to increase clinical trial transparency and visibility to the public, pharmaceutical manufacturers are facing new pressure points. New regulations require the disclosure of clinical trial application data, many of which cont…

Science for all: Is it all about the publication of data, or beyond? - Volume 31, Issue

This article presents an overview of open access initiatives by researchers, journals, government bodies, and regulatory authorities. Open access initiatives are valuable to the scientific community and have increased the amount of clinical research…

Artificial intelligence and machine learning in real-world evidence: Transforming data into actionable insights - Volume 34, Issue

In recent years, the healthcare industry has experienced an exponential growth in the volume of real-world data (RWD) due to advancements in digital health, electronic health records (EHR), wearables, and other data-generating technologies. The…

Lingua Franca and Beyond - Volume 24, Issue

Knowing that the main theme of this issue of Medical Writing is writing for the lay audience, I was thinking hard about what would be the most relevant topic to discuss in the Lingua Franca and Beyond section. My thoughts went to a topic that…

Profile - Volume 26, Issue

The new European medical device regulation and guidance document on clinical evaluation An Interview with Dr Bassil Akra The successor of the currently applicable Medical Device Directives (MDD 93/42/EEC and 90/385/EE) combines both directives…

From data to impact: Exploring the evolution of real-world evidence at the FDA - Volume 34, Issue

The healthcare industry has witnessed a significant shift towards the use of real-world data (RWD) and real-world evidence (RWE) in medical decision-making and treatment evaluation. This article explores the importance of RWE in healthcare…

President’s Message - Volume 33, Issue

Navigating the new era of clinical trial transparency This issue of Medical Writing comes at a time when the summer holidays are behind us. Here’s hoping it has been a relaxing and rejuvenating time for all. As we get back to our day-to-day work,…

A survey on current use of software tools for systematic literature reviews - Volume 32, Issue

Adoption of the EU Medical Devices Regulations and In Vitro Diagnostics Regulations has led to increased demand for systematic literature reviews. This article reports on a survey investigating the current use of software platforms and tools by…

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…

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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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