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Pharmaceutical medical writing competencies: Comparing self-perception with employers' expectations - Volume 21, Issue

In the recently published ‘Pharmaceutical Medical Writing Competency Model’, a group of medical writers describes the knowledge, skills, and behaviours they considered essential for successful medical writers. Thus, this model represents a list of…

Cosmetic regulatory writing - Volume 23, Issue

On 11 July 2013, a new regulation for cosmetics was applied in Europe, Regulation (EC) 1223/2009, replacing Directive 76/768/CEE. This new regulation clarifies the roles and responsibilities of all stakeholders and introduces new notions such as…

Value of medical writing: The regulator's perspective - Volume 31, Issue

In 2020, the American Medical Writers Association established a working group to assess the value of the contribution of medical writers across the health sciences industry, including a subgroup tasked to gather data on the regulatory agency’s…

An overview of the Common Technical Document (CTD) regulatory dossier - Volume 23, Issue

The Common Technical Document (CTD) was designed to provide a common format between Europe, USA, and Japan for the technical documentation included in an application for the registration of a human pharmaceutical product. The CTD dossier is divided…

Regulatory Writing Developments in paediatric regulation - Volume 22, Issue

Recently, both sides of the Atlantic have seen developments in paediatric regulation. In Europe, the EMA has published a new template for the paediatric investigation plan (PIP), which should help dispel some (but by no means all) doubts and…

Regulatory Writing - Volume 24, Issue

The Transatlantic Trade and Investment Partnership (TTIP) has attracted increasing controversy, particularly in Europe. The TTIP is a trade agreement under negotiation between the United States and the European Union, and affects three main areas:…

Regulatory Matters - Volume 29, Issue

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

Regulatory Matters - Volume 29, Issue

Ever since the EMA mandate for plain-language summaries of clinical trials was codified in Clinical Trial Regulation EU No. 536/2014, medical writers have grappled with the task of making these documents accessible to the public, including to…

Regulatory Public Disclosure - Volume 30, Issue

Editorial In the first half of 2021, keeping up with the regional regulators’ activities on COVID-19 medicines became a competitive sport. FDA’s Emergency Use Authorizations (EUAs), EMA’s Conditional Marketing Authorisations, and Health Canada’s…

Regulatory Matters - Volume 32, Issue

Abstract Training: Lessons in self-leadership Kathryn E. White (author), Zuo Yen Lee (section editor), Clre Chang (section editor) More often than not, freelancing means juggling between running a business and writing. Training may not be at 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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