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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…

Medical writing in India at a crossroads - Volume 22, Issue

Pharmaceutical regulatory medical writing for document submissions to Western health regulatory agencies has been undertaken in India for almost 10 years. From humble beginnings in a couple of non-Indian pharmaceutical multinational giants –…

How mentorship has created a special community and helped people develop their careers - Volume 30, Issue

Mentorship is an extremely rewarding relationship between two people with the goal of professional and personal development. Elemed’s Mentoring Academy in partnership with the Regulatory Affairs Professional Society (RAPS) combines three pillars –…

Non-interventional Post-Authorisation Safety Studies (NI-PASS): A different type of report - Volume 23, Issue

Although Post-Authorisation Safety Studies (PASS) have been around since 2001, most regulatory writers would have been unaware of their existence until the recent changes in European regulations, which include mention of these studies as part of…

Pharmaceutical clinical trials transparency and privacy - Volume 29, Issue

With the introduction of new clinical trial transparency regulations around the world, transparency functions have had to adapt to a range of reporting requirements. In 2007, the FDA Amendments Act (FDAAA) established requirements for trial sponsors…

Overcoming confidential information challenges faced by study sponsors today - Volume 32, Issue

As health authorities aim to increase clinical trial transparency and visibility to the public, pharmaceutical manufacturers are facing new pressure points. New regulations require the disclosure of clinical trial application data, many of which cont…

A survey on current use of software tools for systematic literature reviews - Volume 32, Issue

Adoption of the EU Medical Devices Regulations and In Vitro Diagnostics Regulations has led to increased demand for systematic literature reviews. This article reports on a survey investigating the current use of software platforms and tools by…

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…

English Grammar and Style - Volume 22, Issue

We have three articles in this edition. Pamela Haendler's contribution deals with the medical writer as a reviewer and quality checker. Because of their close involvement with all of the documentation on a project, the medical writers involved are…

Unlocking new efficiencies: How structured content authoring is streamlining the production of clinical documents for the pharmaceutical industry - Volume 32, Issue

Current practice requires clinical and regulatory documents to be created and updated manually by medical writers throughout a product’s development. Conventionally, document content is unstructured, with freeform text, figures, and tables that 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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