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Message from the President - Volume 23, Issue

These two years in the Executive Committee flew by. They will remain in my heart for ever. It is difficult to summarise the emotions and the things we accomplished these last two years. When this adventure started in Cyprus, Susan Bhatti, the…

EMWA News - Volume 27, Issue

The Greek philosopher Heraclitus has been credited with the idea that there is nothing perma - nent except change. This certainly pertains to EMWA as we celebrate our 25th year. The first EMWA meeting in 1992 had 32 participants with no workshops.…

Regulatory Matters - Volume 29, Issue

A medical writer’s perspective on the relationship between EMA Policy 0070 and the General Data Protection Regulation

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…

Model-informed drug development in rare diseases - Volume 34, Issue

Model-informed drug development (MIDD) approaches maximise and connect information obtained on a drug during development, allowing better characterisation of its risk: benefit profile. MIDD is especially useful for rare diseases with few patients to…

Medical Communications - Volume 22, Issue

Meeting reports are an aspect of ‘medical’ and other technical writing that has had little discussion. The following might be of interest to medical writers asked to provide rapid, reliable, objective reports of various types of meeting. The United…

Profile: An interview with Professor Peter Jüni on methodology and statistics in scientific manuscripts - Volume 25, Issue

This issue of Medical Writing (MEW) is about statistics, so what is more appropriate than interviewing a research methodologist who focuses on epidemiology and statistics in clinical research? I am happy that we were able to win Professor Peter Jüni…

Towards electronic product information that meets the needs of everyone: Implications for patients, clinicians, and medical writers - Volume 34, Issue

In an age of increasing digitisation, pharmaceutical product information is evolving. This transformation reflects growing recognition among regulators of the value of patient engagement and widespread societal calls for increased transparency of…

The changing face of (benefit-)risk management - Volume 24, Issue

Over the last 20 years the focus of post-approval management of medicines has changed from risk management to the assessment and management of benefit-risk. In the EU this has been reinforced by changes in the legislation underpinning…

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…

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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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