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Health technology assessment (HTA) is a relatively recent innovation that has changed the way decisions are made in healthcare. It is a multidisciplinary process that requires different skill sets and collaboration among various disciplines and…
The International Conference on Harmonisation (ICH) guideline E3 describes the structure and content of clinical study reports (CSRs). However, this standard structure should be interpreted according to the type of study and data, including…
Today, the principles of good clinical practice (GCP) form such an integral part of the development of new medicines that they could easily be taken for granted. Yet, the road to a universal code of ethics in human experimentation is paved with…
Dear All,
As I write this, at least some of us are likely to still be in some form of lockdown or quarantine. I pray that you and your families are all managing to stay as sane as possible, and I sincerely hope that you all stay safe and healthy.
I…
With the introduction of the new EU Legislation in 2012, RMP requirements have changed significantly, triggering content- and process-related changes. An RMP is written as part of a submission dossier and is submitted for assessment to the EMA. The…
Authorship of publications has been the subject of much public debate; however, authorship of clinical trial documents such as clinical study protocols, clinical study reports, investigator’s brochures and inform ed consent forms has not really been…
Clinical writing, a specialised type of medical writing, refers to the types of writing health professionals use on a daily basis such as medical charts and forms. It requires knowledge of both formal and informal medical language and culture. An…
This book is regarded by many as the holy grail of reference manuals. For those not familiar with the great tome it contains a massive amount of information regarding ‘publication style and format for scientific papers, journal articles, books, and…
Drug development forms the core of the pharmaceutical industry. Medical writing is a key function in pharmaceutical companies and clinical research organisations that works on scientific publications and regulatory dossiers. Regulatory writing…
With increasing transparency demands andthe new legal requirements for providingclinical trial information to lay readers, clinicaltrials need to be given titles that patients canunderstand and recognise. Trial titles informthe readers what the…
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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My First Medical Writing
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The Crofter: Sustainable Communications
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