Your search for "harmonisation" matched 360 page(s).
Showing results 111 to 120.
Clinical trial data are rightfully protected by robust regulations; given these requirements and increasing demands from clients, a validated and compliant electronic document management system is now a necessity for established medical writing…
The preparation of pharmacovigilance documents is a global and cross-functional activity. The pharmacovigilance medical writer has a key position in this complex activity, leading the whole document creation process. This process includes drafting…
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…
The Regulatory Expert Seminar session at the 2021 Spring EMWA Conference took us on an amazing journey through marketing authorisation applications from a regulator’s and medical writer’s perspective. One of the presentations focussed on the…
The complexity of modern-day clinical trials has propelled trial design from being a consideration to now becoming what some experts believe is a science in and of itself. The United States Food and Drug Administration (FDA) sees immense potential…
Health Communication: From Theory to Practice by Renata Schiavo; Jossey-Bass, 2013. ISBN: 978-1-118-12219-8 (paperback). 57.50 GBP. 656 pages. An excellent textbook loaded with theory and case studies for practice, but more useful alongside a…
Dear EMWA Members, As you are well aware, we have been celebrating our 25th anniversary as an organisation and have sent out specially designed buttons with the December issue of Medical Writing to commem - orate the occasion. To continue the…
The National Institute for Health and Care Excellence (NICE) is the independent organisation in England responsible for developing national guidance, standards, and information on providing high-quality health and social care, and preventing and…
This is the first systematic comparison of the costs of salaried and freelance medical writers working in Europe. In the absence of official figures for the total costs of employment, we make reasoned assumptions, using mean base figures for…
This paper describes the role of social media in healthcare and medicine based on the example of how a contract research organisation (CRO) uses video interviews to spread knowledge and expertise among professionals. Considering that in coming…
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
Managing Editor
Victoria White
Associate Editors
Section Editors
AI/Automation
Biotechnology
Digital Communication
EMWA News
Gained in Translation
Getting Your Foot in the Door
Good Writing Practice
In the Bookstores
Publications
Medical Communications/Writing for Patients
Medical Devices
My First Medical Writing
News from the EMA
Freelancing
Pharmacovigilance
Regulatory Matters
Regulatory Public Disclosure
Teaching Medical Writing
Louisa Ludwig-Begall / Sarah Kabani
The Crofter: Sustainable Communications
Veterinary Writing
Editors Emeritus
Layout Designer
Chris Monk