Protection of personal data and commercially confidential information under the Clinical Trials Regulation (EU) No. 536/ 2014 – EMA “Revised CTIS Transparency Rules" - Volume 33, Issue

The Clinical Trials Regulation (EU) No 536/2014 (CTR) came in force on January 31, 2022, specifying requirements for performing clinical trials in the EU and the European Economic Area (EEA). The CTR and the Clinical Trials Information System (CTIS)…

Presenting secondary endpoints in plain language clinical trial result summaries: Considerations for emerging practice - Volume 30, Issue

Background: The European Union Clinical Trials Regulation 536/2014 (EU CTR) requires sponsors to submit summaries of clinical trial results in plain/lay language (Plain Language Trial Summaries [PLTS]). A multidisciplinary working group developed…

Lifelong learning opportunitites are available for all - Volume 31, Issue

The United Nations Sustainable Development Goals (SDG) call all UN member states– low-, high- and middle-income – to promote prosperity while protecting the environment. The 17 goals are part “of a shared blueprint for peace and prosperity for…

Medical devices in the disclosure era and the role of medical writers - Volume 26, Issue

AbstractIncreased transparency is one of the provisions of the Clinical Trial and Medical Device Regulations. This article discusses the impact of transparency and disclosure on medical devices. Many modern-day medical devices are software-driven.…

Making medical communication accessible to all: A translator’s perspective - Volume 34, Issue

Language barriers in healthcare can put patients at risk, leading to misdiagnoses, delays in treatment, and exclusion from clinical trials. Clear communication requires cultural adaptation to ensure patients understand and trust the information they…

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…

The Webscout - Volume 21, Issue

Diabetes and Psychology   You all may know that diabetes is a metabolic disease leading to secondary micro- and macrovascular complications, like nephropathy, neuropathy, and cardiovascular diseases. You may also know that these microvascular…

Preparing clinical study reports for external sharing - Volume 27, Issue

As the EMA refines its requirements for the external publishing of clinical study reports, the workload of medical writing teams is increasing to include robust processes for clinical study report anonymisation. Until now, life sciences firms have…

Veterinary Medical Writing - Volume 32, Issue

Abstract Human medicine has recently seen a move away from the paternalistic patient-physician paradigm course to a collaborative one, where “shared decision-making” is a core principle. No longer a passive bystander, where their case management is…

Scientific advice procedures in the EU – an overview ofthe regulatory background - Volume 29, Issue

The prerequisite for obtaining marketing authorisation is an appropriate and robust data package that demonstrates a medicinal product’s quality and its efficacy and safety in the proposed indication. Pharmaceutical companies can face regulatory…