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There is a paradigm shift in the pharmaceutical industry and regulatory agencies towards transparency and an emphasis on the benefit-risk ratio of medicines. The recent changes in legislation surrounding clinical documentation have produced…
‘Why write a clinical study report (CSR)? What are the guidance documents? Can I interpret them? Can I deliver my CSR on time?’ This article addresses these questions – and others, provides a companion guide to CSR authoring for preregistration drug…
Economic liberalisation has led to an influx of clinical research and a boom in the medical writing industry in India. Medical writers in India at present contribute mostly to medical communications, health journalism, and academic medical…
A large proportion of medical writing activities are now outsourced. This means the need for medical writing service providers is growing, and with increased demand there comes an increased supply of providers. The challenge that arises in such a…
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…
For most of us, medical writing is highly technical. We prepare regulatory or clinical documents or write materials targeted to medical doctors. Medical writing for lay audiences is different, and it does not come naturally to most of us because…
Many regulatory medical writers start their careers in pharma. Whilst many continue in pharma, some also work in medical devices and an increasing number are switching to medical device writing. This article explores how and why writers might move…
Instructions for Authors SCOPE Medical Writing, the official journal of EMWA (the European Medical Writers Association), is a quarterly journal that aims to educate, inform, and entertain medical writers. Medical Writing publishes themed issues…
Medical Affairs is a link between the scientific and marketing units of a pharmaceutical company. Medical writers in this field are responsible for writing varied document types from regulatory reports to scientific publications, and marketing…
With the emergence of biosimilars, the development process for these drugs is a topic of increasing interest to medical writers. Even though information and educational documents on the concept of biosimilarity areincreasingly publicly available, it…
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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