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Publication planning and patient-reported outcomes: Demonstrating value in a multi-stakeholder era - Volume 27, Issue

Patient-reported outcomes (PROs) are an essential element to demonstrate the value of a health intervention. In many ways, PROs represent the ultimate “real-world” data, yet the drive towards “Big Data” has focused onroutinely collected data from…

Regulatory submissions of non-interventional post-authorisation safety studies - Volume 26, Issue

The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be submitted in common technical…

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…

The UK pharmaceutical industry braces for Brexit, be it mild, severe, or doomsday - Volume 27, Issue

Pharma-Brexit is on its way. The announcement of the European Medicine Agency’s move to Amsterdam, various UK government white papers, and comments made by key stakeholders in the UK pharmaceutical industry have led to a wide range of predictions…

Gained in Translation - Volume 24, Issue

We often write articles to satisfy two states of mind: pleasure and curiosity. In my case, this means the curiosity to delve into some of the intricacies of translation on the one hand, and, on the other, the desire to work together with colleagues…

Medical Devices - Volume 28, Issue

Medical devices should certainly be included on any list of trends in medical writing. That impression was only reinforced by the strong interest in device writing evident at this year’s EMWA spring conference. The three medical device workshops on…

Out on Our Own - Volume 28, Issue

It is a pleasure for me to share an article in this issue from our previous Out on Our Own (OOOO) section editor, Satyen Shenoy. For those that don’t know him, where have you been? Satyen, as he will describe, has been on the EMWA scene for many…

Regulatory initiatives for artificial intelligence applications: Regulatory writing implications - Volume 32, Issue

Applications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to…

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…

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…

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Scope

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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