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Medical writing for two audiences – The RMP public summary - Volume 24, Issue

With the introduction of the new EU Legislation in 2012, RMP requirements have changed significantly, triggering content- and process-related changes. An RMP is written as part of a submission dossier and is submitted for assessment to the EMA. The…

Science for all: Is it all about the publication of data, or beyond? - Volume 31, Issue

This article presents an overview of open access initiatives by researchers, journals, government bodies, and regulatory authorities. Open access initiatives are valuable to the scientific community and have increased the amount of clinical research…

Transparency through the lens of data protection and privacy: A clinical research organisation medical writing perspective - Volume 33, Issue

Medical writers maintain a fine balance between data transparency obligations and personal data protection in clinical reports. Hence, we must stay informed of data protection requirements outlined in the EU General Data Protection Regulation (GDPR)…

The periodic safety update report and post market surveillance report under the new EU Medical Device Regulation - Volume 31, Issue

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…

Lay summaries for Phase 1 trials in healthy volunteers - Volume 29, Issue

Lay summaries of Phase I trials in healthy volunteers pose a challenge because their endpoints are complex, the targeted indication may not be known when they are conducted, their results are often reported years after the trial ended, and the…

Writing for lay audiences - Volume 24, Issue

For most of us, medical writing is highly technical. We prepare regulatory or clinical documents or write materials targeted to medical doctors. Medical writing for lay audiences is different, and it does not come naturally to most of us because…

From academia to freelance medical writing: Navigating the transition - Volume 32, Issue

Academics who have transitioned to medical communications (MedComms) find that there are many parallels between the two fields, leading to fulfilling and rewarding careers. Many of the skills honed in academia such as research, technical writing,…

Veterinary Medical Writing - Volume 33, Issue

Section Editor: Louisa Marcombes Spotlight on www.LAS-interactive.de: Information for animal experimentation and a useful resource for veterinary medical writers Authors: Cemile Jakupoglu, Jennifer Freymann According to the EU Animal Protection…

Social media scheduling: How not to spam your followers - Volume 30, Issue

Social media is, today, an indispensable part of networking and business. However, many professionals are still learning how to navigate the sea of social media. Big companies have a dedicated department, but small businesses, entrepreneurs, and…

Essential investments in optimising clinical research for rare disease - Volume 34, Issue

The complexities associated with clinical trials for (ultra) rare diseases include regulatory and logistical hurdles and the challenge of building trusting relationships with health authorities, patients, and clinicians. Significant obstacles…

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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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