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Profile: An interview with Ingrid Edsman on why attending EMWA conferences is so rewarding! - Volume 24, Issue

Ingrid Edsman, with 17 years of increasingly senior clinical research positions in the Pharmaceutical Industry, is an expert in the preparation of regulatory and clinical documents. She obtained a Medical Degree at the Karolinska Institute in…

Pharmacovigilance for vaccines and immunotherapies - Volume 27, Issue

Although the content of EU Periodic Benefit- Risk Evaluation Reports (PBRERs) for vaccines is governed by the same regulatory framework as applies to other medicinal products, the complex nature of vaccines presents vaccine-specific challenges that…

Key factors a pharmaceutical company should consider while outsourcing medical writing services - Volume 23, Issue

Medical writing teams are crucial in the pharmaceutical industry at every stage of drug development. With growing regulatory pressure and shrinking profit margins, outsourcing these activities is considered a viable option that provides multiple…

An interview with Cathal Gallagher of EMA’s Technical Anonymisation Group - Volume 29, Issue

In our daily work in a company or freelance setting, we interact with other relevant functions, typically biostatistical, medical, programming, and data management colleagues, so that we can deliver wellrounded deliverables that take account of…

India as a hub for ethical and evidence-based medical communications - Volume 22, Issue

Ethical and evidence-based medical communications are gaining increasing importance in emerging pharmaceutical markets, outside of North America and Western Europe. In large pharmaceutical companies resources are limited, and small and mid-sized…

A beginner´s guide to writing clinical investigation plans and reports for medical devices - Volume 31, Issue

A clinical investigation plan for a medical device must outline and justify all objectives of the clinical investigation, present and justify the investigational design and methodology, and state principal features of the statistical analysis. A…

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…

Non-clinical health writing - Volume 23, Issue

We medical writers have a unique and valuable skill set, which includes, most notably, the ability to understand and clearly communicate complex medical information. We are also experts at working with multifunctional teams, compiling detailed…

President’s Message - Volume 25, Issue

Dear EMWA Members, It is my very great pleasure to ‘speak’ to you from the pages of the very first issue of Medical Writing of 2016, with our new printer, Hastings. I am particularly excited that our feature articles are now open-access – a…

Plain language and readability - Volume 24, Issue

Plain language is writing in clear, concise language that is easy to read and understand. Whenever I hear the term plain language I am reminded of a lay summary I was once asked to edit. The stream of technical language (‘self-source bias’, ‘effect m…

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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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