News and Notes from the World of Medical Writing - Volume 30, Issue

EMWA’s Special Interest Group on Medical Communication initiated a reply to an article that made unfounded derogatory remarks about medical writers (MWs). Without providing any evidence, in an article about the development of randomised clinical…

Transparency and the healthcare industry: The Sun is shining - Volume 22, Issue

The demand for greater transparency in financial relationships between the healthcare industry and healthcare professionals is increasing globally, and has led to establishing government regulations and professional guidelines for detailed reporting…

Bad karma - Volume 22, Issue

Bad Pharma provides a hyper-critical account of the pharmaceutical industry's approach to conducting, publishing and using clinical research and development. However, its attack on the drug regulators is unfair and its examination of the medical…

Journal Watch - Volume 21, Issue

Readability of informed consent forms, sponsor participation in industry trials, and conflict of interest disclosure. Informed consent is a crucial feature of clinical research trials. Guidelines on developing an informed consent form urge writers…

The Write Stuff Archive

The Write Stuff Archive

The Write Stuff was the name of EMWA’s journal starting in 1998 and up until the name was changed to Medical Writing in 2012. This archive contains issues of The Write Stuff dating back to 2002.

Volume: 20 | Issue: 4 | Ye…

An overview of the Common Technical Document (CTD) regulatory dossier - Volume 23, Issue

The Common Technical Document (CTD) was designed to provide a common format between Europe, USA, and Japan for the technical documentation included in an application for the registration of a human pharmaceutical product. The CTD dossier is divided…

RCTs: Can the treatment work? Patient registries: Does the treatment work? - Volume 26, Issue

The first part of this article compares the main features of studies based on patient registry data with those of randomised clinical trials, providing a basis for better understanding the differences between the two. The second part details how to…

GPP3 – what is it, why is it necessary and what is new? - Volume 25, Issue

The good publication practice for pharmaceutical companies (GPP) guidelines were first published in 2003, then revised in 2009 (GPP2) and most recently in 2015 (GPP3). The latest version reflects the changes that have occurred in legislation…

Statistical principles in biosimilar development - Volume 28, Issue

Unlike new drug development where superiority over an active comparator or placebo often has to be proven, biosimilar development focuses on showing similarity of the proposed biosimilar to an already approved reference product. This affects…

Allergen immunotherapy in the European regulatory environment - Volume 27, Issue

Allergen immunotherapy (AIT) modulates the immune system to prevent and relieve allergic symptoms. Unlike allergen avoidance and medication to control symptoms, AIT targets the underlying pathophysiology of allergic diseases. AIT is now considered a…