Your search for "regulations" matched 574 page(s).
Showing results 191 to 200.
Passing the torch: Reflections on my tenure as president Medical Writing. 2025;34(2):8. https://doi.org/10.56012/ohoz5167
HR-QoL measurements attempt to turn subjective information into objective information. In this article, I describe the different kinds of health-related quality of life (HRQoL) measures, how they work, and how they can be interpreted. Main types of…
Canadian and European regulators finalised guidelines that allow for sharing of clinical trial data. To maintain the utility of clinical information, risk-based anonymisation techniques are recommended. It behoves applicants to ensure organisational…
September 14, 2020 – The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its workplan which sets actions to be delivered in 2020–2021. With the European Medicines Regulatory Network focused on the…
The quest for transparency in the relationships between life sciences companies and healthcare professionals is quickly becoming a global movement. Reporting requirements for financial interactions have been prevalent in the United States for many…
Medical device manufacturers must continuously evaluate all clinical data available for their products marketed in Europe. With the European Medical Device Regulation 2017/745 coming into force in May 2021, manufacturers are required to assess…
Spotlight on similar devices under the Medical Device Regulation This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market…
If economic evaluations are to be used by researchers and healthcare decision makers, they need to be adequately reported. This article discusses the update of the Consolidated Health Economic Evaluation Reporting Standards (CHEERS 2022), the main…
Editorial We may pose many questions about translation, but the most frequent in the specific literature is “why translation matters?” In my opinion, however, the question should be rephrased as, “For whom is translation important?” The answer…
This essay outlines the broad themes of the conspiracy theory that pharmaceutical companies, regulators, politicians, and others are secretly working in consort against the public interest. This so-called Big Pharma conspiracy theory shares a number…
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:
Editor-in-Chief
Co-Editors
Senior Editor
Victoria White
Managing Editor
Alicia Brooks Waltman
Associate Editors
Section Editors
AI/Automation
Biotechnology
Digital Communication
EMWA News
Freelancing
Gained in Translation
Getting Your Foot in the Door
Good Writing Practice
Pablo Izquierdo / Alison McIntosh
In the Bookstores
Publications
Medical Communications/Writing for Patients
Medical Devices
My First Medical Writing
News from the EMA
Pharmacovigilance
Regulatory Matters
Regulatory Public Disclosure
Louisa Ludwig-Begall / Sarah Kabani
The Crofter: Sustainable Communications
Veterinary Writing
Editors Emeritus
Layout Designer
Chris Monk