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November 15, 2016 — The EMA, in cooperation with the European Commission and the Member States of the EU, is proposing changes to its existing guideline on first-in-human clinical trials, to further improve the safety of trial participants. The…
What a busy time! The EMWA Professional Development Committee, the Conference Team, and the Executive committee are working very hard on organising the virtual conference in November, which we hope will be a unique experience for you. The…
Pesticides, also known as crop protection products, are approved for sale through a process similar to that for authorising human medicines. For example, the toxicology data submitted are nearly identical to the nonclinical data generated for a…
The new EU Medical Device Regulation 2017/745 (MDR) requires companies to provide a periodic safety update report (PSUR) and a post market surveillance report (PMSR). Creating these reports will strengthen the post market surveillance and vigilance…
Although Post-Authorisation Safety Studies (PASS) have been around since 2001, most regulatory writers would have been unaware of their existence until the recent changes in European regulations, which include mention of these studies as part of…
In this edition of OOOO, we are pleased to bring to you four diverse and thought provoking articles, and some practical tips. We thank you for your contributions and once again invite you to submit any articles that you wish to share with your…
Medical devices range from things as simple as an injection needle to implantable pacemakers and MRI imaging devices. A video by the WHO (http://t1p.de/WHOVideo) gives you an impression of the variety of medical devices and their importance for…
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…
There is a growing debate in journals and articles on financial and non-financial conflicts of interest (COIs). This debate exists in scientific journals and also in the mainstream media. I provide two examples: the New York Times (NYT) and JAMA.
Almost everyone uses Microsoft Word® – but do you use its standard functions to the full to make your job easier? It is worth spending a little time getting to know how you can exploit functions like ‘Find and Replace’ or change or understand some…
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
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Chris Monk