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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)…

Real-world evidence and real-world data in contemporary healthcare: A critical overview - Volume 34, Issue

The European Medicines Agency (EMA) has increasingly recognised the value of real-world data (RWD) and real-world evidence (RWE) in this ever-changing regulatory landscape. Regulatory decisions have been traditionally based primarily on data from…

Real-world data and evidence: A European regulatory perspective - Volume 34, Issue

Expanding the safety horizon: How real-world evidence shapes drug safety - Volume 34, Issue

Real-world evidence (RWE), generated from real-world data (RWD), is pivotal in evaluating the safety and effectiveness of medical treatments beyond the controlled settings of clinical trials. Unlike randomised controlled trials (RCTs), which often in…

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…

About the Medical Writing Journal - Volume 21, Issue

The official journal of the European Medical Writers Association (EMWA) has changed its name from The Write Stuff to Medical Writing, which is being published by Maney Publishing. This marks a leap forward for the journal, which is now in its 19th…

Medical Communications - Volume 22, Issue

Having left the office for 5 days to go to the EMWA Spring Conference, I returned to the obligatory email avalanche. While it was mostly junk (and unfortunately still no ‘congratulations on winning the lottery’ message…), there were some messages…

Good Writing Practice - Volume 21, Issue

The Good Writing Practice initiative was launched in the December 2010 issue of TWS1 by Alistair Reeves and Wendy Kingdom. The aim is to go beyond the classic style guide and provide advice on practical aspects of writing that make texts easier to…

Global perspectives on EDIB: Advancing equity, diversity, inclusion, and Belonging in medical communications - Volume 33, Issue

The integration of Equity, Diversity, Inclusion, and Belonging (EDIB) principles within the field of medical communications is of paramount importance. EDIB principles, aligned with global guidelines on sustainability – encompassing labour…

Good pharma - Volume 22, Issue

Drugs companies publish only a fraction of their results and keep much of the information to themselves. Drug companies are ‘debasing’ drug trials whose publication in journals can apparently confer scientific approval. Merck had fought for years to …

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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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