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News from the EMA - Volume 32, Issue

Anuradha Alahari (section editor) EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo OPEN framework extended to a wider range of medicines Global regulators agree on way forward to adapt COVID-19 vaccines to…

Regulatory Public Disclosure - Volume 28, Issue

In the world of regulatory public disclosure (RPD) things rarely stay the same for long. This regular RPD section in Medical Writing and EMWA’s RPD SIG help you keep up.

Value of medical writing: The regulatory writer's perspective - Volume 31, Issue

The American Medical Writers Association formed a working group in 2020 focused on understanding and communicating the value that regulatory medical writers contribute to project teams, companies, and the wider research community. The working…

Update of the Consolidated Health Economic Evaluation Reporting Standards: CHEERS 2022 - Volume 31, Issue

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…

Gained in Translation - Volume 21, Issue

Science at the multilingual crossroads With Medical Writing's third issue, this seems to be a good time to recall why this journal features a section on multilingual aspects – and why this section is called what it's called. Medical writing,…

Foreword: Writing for Patients, Foreword from the EMA - Volume 29, Issue

In recent years, regulators across the globe have improved the way they communicate to patients and the general public about their activities and how medicines are regulated.

The use of machine translation and AI in medical translation: pros and cons - Volume 33, Issue

In this article, I provide a retrospective look at the emergence of translation technologies and summarise the pros and cons of the use of neural machine translation and generative AI tools in medical translation. I will examine both the advantages…

Building resilience: Navigating challenges and thriving among the demands of regulatory writing - Volume 33, Issue

Regulatory writing is a demanding yet rewarding profession in which writers help pave the way for groundbreaking healthcare innovations that improve the lives of patients. However, as critical as our work is, regulatory writing is full of challenges…

Medical Writing

Pharmacovigilance - Volume 31, Issue

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…

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Scope

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.

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