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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:…
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 past two years have confronted humanity with a variety of unprecedented challenges due to the far-reaching COVID-19 pandemic. In response to this tragedy have come monumental new advances in science and technology – namely the vaccines developed…
The phenomenon of missing data is ubiquitous in clinical studies. Both the extent of missing data and the structure of missing data can introduce bias into study results and lead to wrong conclusions. Medical writers should be aware of the extent of…
In 2021, EMWA members were asked to participate in a survey about their current salary and compensation. The survey included questions on some of the factors that typically influence earnings, such as education, geographic location, level…
An estimated 85% of efforts in biomedical research are wasted due to inefficiencies. This wastage represents a global financial loss of greater than US$200 billion per year, a barrier to practicing evidence-based medicine, and a considerable amount…
Health literacy is defined as “the knowledge, motivation, and competence to access, understand, appraise and apply information to make decisions in terms of healthcare, disease prevention, and health promotion” according to Quaglio et al.5 Poor…
Unwarranted changes by the client, lengthy approvals, and multiple rounds of revision – localisation of promotional materials for pharmaceutical companies can become a nightmare if the localisation specialist is unaware of heavy regulations in the…
The surge in artificial intelligence (AI) prompts a reassessment of linguistic validation methods for patient-reported outcome (PRO) measures. The robust linguistic process, designed to adapt PRO measures for different cultures and languages, is…
The European General Data Protection Regulation 2016/ 679 (GDPR) aims to ensure the security and privacy of individuals in the European Union (EU). Companies located within and outside of the EU must comply with GDPR when processing personal data…
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
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Victoria White
Deputy Managing Editor
Alicia Brooks Waltman
Associate Editors
Section Editors
AI/Automation
Biotechnology
Digital Communication
EMWA News
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Gained in Translation
Getting Your Foot in the Door
Good Writing Practice
Pablo Izquierdo / Alison McIntosh
In the Bookstores
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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
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Chris Monk