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Out on Our Own - Volume 30, Issue

Editorial Welcome readers, I’ve lost count how many times people ask me, what is a medical writer? And it isn’t just my mum and aunt who ask me such a question; medical doctors, PhD students, and academic professors are often surprised that…

Medical writing in the Middle East - Volume 22, Issue

Medical researchers in Middle Eastern countries have been forced to confront the fact that scientific publication has become the cornerstone of knowledge dissemination and academic promotion. Regional initiatives, such as the foundation of the…

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…

Responding to concerns over the PSMF: Inspectors offer key insights - Volume 23, Issue

The pharmacovigilance system master file (PSMF) is a detailed description of the pharmacovigilance system used by the marketing authorisation holder for their authorised medicinal products. The PSMF is intended to be a live, custom-made document…

News from the EMA - Volume 26, Issue

April, 6, 2017 – Following two years of experience with safety monitoring of nationally authorised medicines via the single assessment of periodic safety update reports (PSURs), the EMA has issued additional guidance and recommendations as part of…

Regulatory Writing Briefing documents: A case apart - Volume 24, Issue

Health authority briefing documents (also known as briefing packs, briefing packages, and briefing books) are documents prepared by a pharmaceutical company to support its interactions (e.g. pre-submission meetings, requests for scientific advice,…

Clinical trial disclosure landscape and awareness in Japan - Volume 28, Issue

While disclosure of individual clinical study reports (CSRs) is becoming common globally, this is not yet the case in Japan, where the national health authority does not require CSRs to be made publicly available. As CSRs of Japanese studies might…

Veterinary Medical Writing - Volume 28, Issue

With veterinary treatment options becoming more diverse and advancing rapidly, the demand for veterinary medical writers is growing. Currently we are a growing group of vets in EMWA and we look forward to welcoming more colleagues to our…

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…

Clinical trial disclosure: Perspective from a medical writer for a contract research organisation - Volume 28, Issue

In this article, I summarise how, as a medical writer with over 20 years of experience in regulatory writing, all with a contract research organisation, I transitioned into the world of disclosure and how I now have my feet firmly in both camps:…

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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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