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EMWA news - Volume 21, Issue

News from the EMWA Website Manager New role At the recent EMWA conference held in Cyprus, I assumed the position of EMWA Website Manager. While this is a daunting task, it is a challenge I am pleased to take on. To ensure that I was in a…

Medical Writing

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…

News from the EMA - Volume 26, Issue

November 15, 2016 — The EMA, in cooperation with the European Commission and the Member States of the EU, is proposing changes to its existing guideline on first-in-human clinical trials, to further improve the safety of trial participants. The…

Letter to the Editor - Volume 25, Issue

Dear Editor, EMWA and other organisations (eg, AMWA, ISMPP) support the principles of Good Public at - ion Practice (GPP). As a co-author of the recent GPP3 guideline1 and leader of the professional medical writer section, I was concerned by a…

Veterinary Medical Writing - Volume 29, Issue

Cemile Jakupoglu of Cyton AH Biosciences GmbH and Maggie Fisher of Veterinary Research Management give the Veterinary Medical Writing section of the journal an overview of some major changes involved in therevision of the “Guideline on the conduct…

Clinical Evaluation Reports from the medical writer’s perspective! - Volume 26, Issue

Abstract Clinical evaluation is a structured ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device. The clinical data include current knowledge of the condition to be treated, published literature about the…

Some considerations on the safety evaluation section of clinical study reports for studies with anticancer drugs - Volume 21, Issue

The International Conference on Harmonisation (ICH) guideline E3 describes the structure and content of clinical study reports (CSRs). However, this standard structure should be interpreted according to the type of study and data, including…

Pharmacovigilance medical writing: An evolving profession - Volume 24, Issue

The preparation of pharmacovigilance documents is a global and cross-functional activity. The pharmacovigilance medical writer has a key position in this complex activity, leading the whole document creation process. This process includes drafting…

Clinical evaluation reports: 6 years after the introduction of MEDDEV 2.7/1 revision 4 - Volume 31, Issue

MEDDEV 2.7/1 is the European guideline about the clinical evaluation of medical devices. The 4th revision, in 2016, updated how clinical evaluation should be conducted and reported, thus paving the way for clinical evaluation under the Medical…

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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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