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Medical writing for in vitro diagnostics: A different approach for the ‘hidden’ side of healthcare - Volume 23, Issue

Medical writing for in vitro diagnostics differs from writing for pharmaceutical products in several ways. The shorter development time and lifecycle of diagnostic assays, different regulatory requirements and approval times, and upcoming changes…

Good medical writing saves lives: The perspective of a former medic - Volume 26, Issue

Making the decision to leave medicine was the hardest of my life. What if all those years of study, thousands of pounds of debt and sacrifices I made were not wasted but instead prepared me for my most gallant career yet – medical writing? Believing…

Writing for orphan drugs: A compass to navigate document types and regional requirements - Volume 34, Issue

Medical writing for rare diseases encompasses the development of various regulatory documents that are required to obtain orphan drug designation and marketing authorisation for treatments targeting rare conditions. Effective planning and close…

Clinical trial transparency and disclosure from the medical writing perspective - Volume 33, Issue

It’s been more than 6 years since our last Medical Writing edition dedicated to clinical trial transparency and disclosure. Since then, we have seen the full implementation of the long-awaited EU Clinical Trials Regulation (CTR), the pause and restar…

An interview with Julia Cooper: Insights and experiences from leading a global medical writing team - Volume 33, Issue

Julia Cooper, PhD, is the Corporate Vice President and Head of Medical Writing Services at Parexel. In this interview, she shares her insights on the different aspects of leading a global medical writing team and on how she and her team at Parexel…

Regulatory initiatives for artificial intelligence applications: Regulatory writing implications - Volume 32, Issue

Applications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to…

Overview of the European General Data Protection Regulation (GDPR) impact on medical writing for clinical trials - Volume 32, Issue

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…

Profile - An Interview with Juliane Chaccour - Writing in Mozambique - Volume 25, Issue

On her private Twitter profile, Julie (Juliane) describes herself as “freelance medical editor, mother, immunologist with an interest in tropical diseases and vaccines”. Julie works as a freelance medical writer and editor, is managing editor at…

One size doesn’t fit all: Tailored medical writing mentoring and training - Volume 30, Issue

While there is ultimately no “secret sauce” to mentoring, in this article I outline my nonnegotiables, which, although not rocket science, often take the mentor’s concerted effort to implement. Firstly, everyone is different. While hardly…

Addressing vaccine hesitancy in writing: How has COVID-19 changed hesitancy communication, and what works? - Volume 30, Issue

To address vaccine hesitancy in writing, it is important to put yourself in your reader’s shoes, demonstrate an understanding of the hesitancy, and form an effective response using evidence-based writing techniques, clear communication, courtesy,…

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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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