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This article discusses the fast-approaching deadline for sponsors to transition ongoing clinical trials in the EU/European Economic Area from the Clinical Trials Directive 2001/20/EC to the Clinical Trials Regulation 536/2014. In particular, the…
The EU regulatory system is undergoing a major overhaul. Several new pieces of legislation are now in place to enforce harmonisation and transparency in clinical trials while ensuring data security and individual privacy. New and aspiring medical…
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…
Regenerative medical products derived from animal tissue have been used to successfully treat millions of patients. As they are manufactured from animal sources, there are bio-contamination and biocompatibility risks that must be addressed in…
Section Editor: Payal Bhatia EMWA’s medical device expert seminar series brings together speakers with different expertise providing valuable insights into the medical device industry. Medical device Expert Seminar Series: Beyond traditional…
Writing for lay audiences is recognised as a difficult task for medical writers, whose specialised knowledge can often hinder effective lay communication. This task is even more challenging when preparing clinical trial information for a…
A skilled mentor can positively impact a mentee’s personal and professional development. A successful mentor-mentee relationship is contingent on mentor and mentee attributes, trust, and respect, and fit based on shared values and working style. To…
Dear members, I am delighted to launch the Pharmacovigilance (PV) section in this journal issue! Those of you who have been around for a while may know that, in the past, PV-related articles were published either as feature articles or as guest…
Co-development, co-delivery, and evaluation of a Medical Writing module at master’s level Few universities offer courses in medical writing, and students from the biomedical sciences who wish to become medical writers typically need to learn…
Preprints: Why and how to use them Section Editor and Author: Maddy Dyer Preprints are a key part of science communication and publication strategy. Medical writers should therefore help inform authors about preprint options. In this article, I…
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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