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Profile: An interview with Laura Carolina Collada Ali: On the peculiarities of working for independent research organisations - Volume 24, Issue

Laura C Collada Ali wears different hats: she is a medical writer plus a medical translator, and has extensive experience delivering multilingual authoring and translation services across a wide range of independent research organisations. She is a…

Getting Your Foot in the Door - Volume 28, Issue

The Vienna Conference is done and dusted. But the aftermath is so rewarding, as my knowledge has broadened and my network has widened. It was a joy to meet old colleagues but also get to know many people who are new to medical writing. In this…

Clinical study reports: A snapshot for aspiring medical writers - Volume 32, Issue

Clinical study reports (CSR) are detailed documents that provide a comprehensive and transparent account of the conduct and results of a clinical trial. They are an important source of information for the regulatory authorities, healthcare…

Global and multidisciplinary perspectives on collaboration with medical writers - Volume 33, Issue

Medical writers, document quality reviewers, and document specialists work together to produce high-quality clinical and regulatory documents. Cross-functional collaboration with other functional leads like bio statisticians, medical monitors, and…

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…

Translating medical devices: A rule-driven game - Volume 33, Issue

Translation for medical devices often presents a unique set of challenges arising from the products’ complex natures and associated regulatory requirements. Beyond medical expertise, linguists – from translators and editors to bilingual quality…

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…

EMA Foreword - Volume 32, Issue

The EU Clinical Trials Regulation and its much-anticipated benefits: Foreword from the European Medicines Agency The year 2022 signalled the beginning of a new way of handling clinical trials in Europe, with the implementation of the EU Clinical…

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…

Clinical trial disclosure: Perspective from a medical writer for a contract research organisation - Volume 28, Issue

In this article, I summarise how, as a medical writer with over 20 years of experience in regulatory writing, all with a contract research organisation, I transitioned into the world of disclosure and how I now have my feet firmly in both camps:…

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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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