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Writing applications for Paediatric Investigation Plans and waivers - Volume 21, Issue

Under EU legislation, a Paediatric Investigation Plan (PIP) and/or a waiver must be agreed in advance with the European Medicines Agency (EMA), for all new medicinal products seeking marketing authorization; the same applies for already authorized…

ADHD: A true neurodevelopmental disorder? - Volume 21, Issue

Attention-deficit/hyperactivity disorder (ADHD) is one of the most common childhood disorders. First described in 1798 by Alexander Crichton, ADHD became widely known outside the medical profession with the publication of the story of Fidgety Phil…

An introduction to medical affairs for medical writers - Volume 28, Issue

The role of medical affairs in pharmaceutical and medical device companies is gaining prominence. Medical writers will increasingly find themselves supporting medical affairs activities or, indeed, transitioning to jobs within medical affairs…

Reporting non-interventional post-authorisation safety studies (NI-PASS) - Volume 26, Issue

Post-authorisation safety studies (PASS), whether interventional or, more commonly, non-interventional (NI), can be used by entities such as the European Medicine Agency´s Pharmacovigilance and Risk Assess ment Committee to oblige drug companies to…

The Webscout - Volume 25, Issue

When did mankind start using statistics and for what purposes? The history of statistics includes names like Bernoulli, Laplace, Gauss, Bayes, and Pearson. I guess you will have heard of some or all of these famous people, whose theories still play…

Regulatory submissions of non-interventional post-authorisation safety studies - Volume 26, Issue

The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be submitted in common technical…

Setting up for success: An overview of why mentoring matters for aspiring medical writers - Volume 30, Issue

The most successful people attribute their success to an effective mentoring network. Developing a great mentor network is critical to ensuring long-term professional development and growth. This article presents an overview of the mentoring…

EMWA News - Volume 27, Issue

We recently announced with deepest sadness the loss of Nicky Dodsworth, a long-term EMWAsupporter and workshop leader. Nicky enriched our educational programme with her knowledge and our hearts with her bright personality. We are thankful for her…

EMWA News - Volume 29, Issue

We are sad to report that Carolina Rojido has had to step down from the EMWA Professional Development Committee (EPDC). Carolina has made a fantastic contribution, not only to the webinar programme but also to other EPDC activities. We are very…

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…

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Scope

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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