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Public perceptions of health information generated by AI: A research study - Volume 34, Issue

Artificial intelligence (AI) integration in clinical practice has intensified in the last few years, from systems analysing and interpreting existing data to generative AI systems capable of creating new information and offering new possibilities…

Implications of clinical trial data sharing for medical writers - Volume 22, Issue

Major clinical research funders are increasingly adopting policies supporting or mandating data sharing. These moves should improve the transparency and availability of clinical trial data and are likely to impact the work and responsibilities of…

Writing reports of modelling and simulation analysis: Our experience in the field of pharmacometrics - Volume 32, Issue

Pharmacometric analyses generate mathematical models that can describe and simulate the pharmacokinetics and pharmacodynamics of drugs. The role of these modelling and simulation (M&S) analyses is growing both in drug development and regulatory…

Protection of personal data and commercially confidential information under the Clinical Trials Regulation (EU) No. 536/ 2014 – EMA “Revised CTIS Transparency Rules" - Volume 33, Issue

The Clinical Trials Regulation (EU) No 536/2014 (CTR) came in force on January 31, 2022, specifying requirements for performing clinical trials in the EU and the European Economic Area (EEA). The CTR and the Clinical Trials Information System (CTIS)…

The need for community: The importance of networking as a freelance medical writer - Volume 32, Issue

Community and networking activity can really help when you are a freelancer. Who do you turn to when it all gets too much? Can someone, anyone, who understands your challenges, offer a sympathetic ear and help to work out a solution? Where do…

From the Editor - Volume 32, Issue

The D’s of robotics: Are we ready to delegate? When Shiri Diskin and Daniela Kamir suggested in 2021 to have a Medical Writing issue on automation in medical writing, little did I imagine how imperative this topic would be in 2023. I sincerely…

How FAIR are pharma publication data? - Volume 31, Issue

Sharing research data increases reusability, reduces waste, supports reproducibility and promotes innovation. In medical research, sharing data also promotes transparency and access to information relevant to patient care. While important…

The Crofter: Sustainable Communications - Volume 33, Issue

Section Editor: Kimi Uegaki Breaking barriers in sustainable development in East Africa: How Lightup Impact is leveraging communications to shift the power to the right actors Authors: Nicole Bezuidenhout, Valeria Santoro, Jeniffer Muganda …

Profile - Volume 26, Issue

The new European medical device regulation and guidance document on clinical evaluation An Interview with Dr Bassil Akra The successor of the currently applicable Medical Device Directives (MDD 93/42/EEC and 90/385/EE) combines both directives…

News from the EMA - Volume 23, Issue

Update from the European Medicines Agency on development of its policy on publication and access to clinical-trial data From the European Medicines Agency, 13 November 2013 – The European Medicines Agency is currently reviewing and analysing…

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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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