Trial Trivia - Volume 32, Issue

We all know there is nothing trivial about clinical trials. But let’s have some light fun and the try answering the short quiz about the topic.

Medical Writing. 2023;32(1)53, 65

EMA Foreword - Volume 32, Issue

The EU Clinical Trials Regulation and its much-anticipated benefits: Foreword from the European Medicines Agency The year 2022 signalled the beginning of a new way of handling clinical trials in Europe, with the implementation of the EU Clinical…

Medical Devices - Volume 32, Issue

Spotlight on similar devices under the Medical Device Regulation This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market…

Science for all: Is it all about the publication of data, or beyond? - Volume 31, Issue

This article presents an overview of open access initiatives by researchers, journals, government bodies, and regulatory authorities. Open access initiatives are valuable to the scientific community and have increased the amount of clinical research…

Abstracts from the 57th EMWA Conference Poster Session - Volume 33, Issue

EMWA’s spring conference in Valencia featured 18 posters on a wide variety of topics of interest to medical writers. Clinical trial regulations, plain language summaries, graphical abstracts, and document quality control are just a few of the…

Never say never! Returning to full-time employment after freelancing - Volume 25, Issue

Alison McIntosh successfully operated as a freelance medical writer for 14 years and gave up the ‘flexible lifestyle’ of a selfemployed freelance medical writer to become a full time employee. She has joined a growing band of ‘decentralised’ office…

Regulatory Public Dislcosure - Volume 32, Issue

In this information-packed edition of Regulatory Public Discussion, Sam Hamilton provides detailed comparisons of regulatory templates and updates on processes for the Clinical Trials Information System. Contributor: Sam Hamilton (author and…

News from the EMA - Volume 32, Issue

This roundup of news from the EMA includes information on vaccines to protect against dengue, therapy to treat transplant patients with post-transplant lymphoproliferative disease, the withdrawal of marketing authorisations for amfepramone…

Regulatory pathways for development and submission activities - Volume 28, Issue

This article discusses how different regulatory requirements for a dossier requesting marketing authorisation for a medical drug affect the deliverables from development functions and the submission groups including medical writing. The content of…

Translating “medicalese”: The case of informed consent forms - Volume 33, Issue

Informed consent forms (ICFs) are documents used in clinical research to inform prospective participants about – and obtain their consent for – partaking in a clinical trial. Evidence suggests that ICFs may not be fit for purpose because their…