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The prerequisite for obtaining marketing authorisation is an appropriate and robust data package that demonstrates a medicinal product’s quality and its efficacy and safety in the proposed indication. Pharmaceutical companies can face regulatory…
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…
In recent years, a myriad of software has revolutionised the translation sector. This article presents a series of translation tools commonly used in the translation industry, depicting their main features and the way they have transformed the…
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…
Following an extensive period of drafting, consultation, negotiation, and re-drafting the new European Legislation came into effect in July this year. The new measures will be the biggest change to medicines legislation since the creation of the…
Greetings, readers.In this issue of OOOO, we start off with an important question – how do I prevent the risk of working too much? An apt question as we approach the end of the year, finishing up our projects and settling in to enjoy the holiday…
We hope that everybody is safe and well – as far as this is possible in the current scenario. COVID-19 is affecting every part of our lives, but we will try our best to help you through these times. Even though the Spring Conference in Prague had to…
Freelancing offers an ideal way of making a living for many of us, providing the opportunity to work from home, and be our own boss. However, working for yourself comes with its own set of challenges and is definitely not an easy option. Success is…
In May 2019 EMWA established a Sustainability Special Intrest Group (SUS SIG). The SUS SID aims to bring sustainability goals into EMWA as an organisation and helps disseminate information for medical writers and medical communicators on being more…
Making the leap to become a freelancer is daunting enough, but once established how do we ensure our business has staying power? Thank you to our experienced freelancers who share their top tips for longevity. Never let it be said that OOOO is…
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