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Abstract The inherent differences between medical devices and drugs have implications for clinical research and medical writing. In view of the current move to more stringent regu - latory requirements for the medical device industry, an increasing…
The recent publication of the book Bad Pharma by Ben Goldacre1 has caused quite a stir in the medical writing community (and indeed throughout the pharmaceutical industry).
The good publication practice for pharmaceutical companies (GPP) guidelines were first published in 2003, then revised in 2009 (GPP2) and most recently in 2015 (GPP3). The latest version reflects the changes that have occurred in legislation…
Criticising the pharmaceutical industry is a type of sport, and it is astonishing what nonsense people will believe about it. For example, it has been said that pharmaceutical companies will only conduct a clinical trial against another product that…
The European Medicine Agency's draft policy on the publication of clinical trial data for consultation (POLICY/0070, EMA/240810/2013) is causing quite a stir. The draft policy provides for the publication of large parts of the clinical study reports…
Sustainable supply As medical writers/ communicators who provide services to pharmaceutical companies, we are part of a pharmaceutical company’s supply chain. In this issue, we follow-up on EMWA’s November 2022 Expert Series Seminar (ESS) on…
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…
It is my privilege to present you the Medical Writing special issue garnering the current Trends in the Medical Writing sphere. With the perpetual amendments in the pharmaceutical industry and the ever-evolving approaches in operating and…
Art Gertel (AG), with nearly 40 years of increasingly senior management level positions in the pharmaceutical industry, is an expert in the preparation of large, complex corporate and regulatory documents and is thoroughly familiar with relevant US,…
The majority of medical writers (either in the pharmaceutical industry, CROs, or as freelancers) provide documents for regulatory authorities. A smaller proportion works in the medical and health communication field writing texts for either…
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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