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The etiquette in clinical trial research requires companies to respect rules and to be precise and accurate. The new EU Clinical Trials Regulation 536/2014 (EU CTR) pushes companies and health authorities one step further – to be more flexible and…
Suzanne Halliday, D.Phil., is the Vice President for Regulatory within the Notified Body BSI with extensive experience in compliance to the Medical Devices Directive (MDD), ISO 13485, risk management, clinical evaluations and investigations, meeting…
The new EU Medical Device Regulation 2017/745 (MDR) requires companies to provide a periodic safety update report (PSUR) and a post market surveillance report (PMSR). Creating these reports will strengthen the post market surveillance and vigilance…
In 2020, the American Medical Writers Association established a working group to assess the value of the contribution of medical writers across the health sciences industry, including a subgroup tasked to gather data on the regulatory agency’s…
Although closely linked to human health, veterinary science remains a relatively unexplored field for medical translators. The key to the specialisation may lie in the translators' ability to answer several key questions: • Who is the…
Following an extensive period of drafting, consultation, negotiation, and re-drafting the new European Legislation came into effect in July this year. The new measures will be the biggest change to medicines legislation since the creation of the…
A medical writer’s perspective on the relationship between EMA Policy 0070 and the General Data Protection Regulation
A document template is defined as ‘a file that serves as a starting point for a new document’. This article looks at the specialised templates used by medical writers in their trade with a focus on the commercially available products. Templates…
Health economic evaluations are relevant to those making healthcare resource allocation decisions, such as listing a new drug on the national formulary or launching a new vaccination programme. Compared with clinical studies that report only the…
Medical writing knowledge and skills can be applied relatively easily to other areas of technical regulatory writing, with a bit of home study. One such area is in the compilation and write-up of REACH (Registration, Evaluation, Authorisation, and…
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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