Reporting non-interventional post-authorisation safety studies (NI-PASS) - Volume 26, Issue

Post-authorisation safety studies (PASS), whether interventional or, more commonly, non-interventional (NI), can be used by entities such as the European Medicine Agency´s Pharmacovigilance and Risk Assess ment Committee to oblige drug companies to…

Covering a medical advisory board meeting and creating the report or publication: The role of the professional medical writer - Volume 25, Issue

Medical advisory board meetings are anintegral part of the healthcare and, inparticular, the pharmaceutical landscape.These meetings serve to identify knowledgegaps in a specific therapeutic area and tosuggest measures that could be implementedand…

How remote working can affect mental health: Work-life balance and meeting fatigue - Volume 31, Issue

When it comes to remote working, we often think about the many benefits this approach brings, such as being more flexible and productive, or improving our work-life balance. However, remote working without the right framework to profit from all…

Quality control: getting the best out of your review - Volume 21, Issue

In medical writing, quality control (QC) means ensuring that a document's content, style, and format are of high quality. This does not just ‘happen’ but is the result of a systemic QC review. These reviews are critical because mistakes can cause…

Jumping over and through the obstacles: Navigating the freelance landscape - Volume 32, Issue

This article explores the major challenges and strategies for succeeding as a freelance medical writer. It covers several topics, including finding enough work, managing heavy workloads, ensuring document quality, and carving out time for…

Making the leap: Transparency requirements for clinical trials moving from one regulatory framework to another - Volume 33, Issue

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…

#EMWATogetherApart - Volume 30, Issue

Dear colleagues, friends, and EMWA community, We hope you all had an exciting and educational 52nd EMWA conference. On behalf of the EMWA Executive Committee, I had great pleasure in welcoming you to the first Hybrid Opening Conference Day on…

Regulatory Matters - Volume 30, Issue

Calling all medical writers:

Focus your writing with lean authoring

In today’s medical writing environment, authors are routinely faced with expedited timelines to write documents about highly complex studies with overwhelming amounts of data. Revi…

AI/Automation - Volume 34, Issue

Section Editor: Daniela Kamir Exploring Research Rabbit: Your new favourite reference manager Author: Natasha Fallico   Medical Writing. 2025;34(1):67–69. https://doi.org/10.56012/wxzm3433

EMWA News - Volume 25, Issue

A lot was going on from April to June this year. Certainly the main event was our spring conference in Munich. Aside the established workshops, Freelance Business Forum, Expert Seminar Series, and updates on Special Interest Groups – it included an…