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Unlocking the power of emotional intelligence in medical writers - Volume 33, Issue

Emotional intelligence (EI), the ability to recognise and understand emotions (one’s own and those of other people), is a valuable attribute for medical writers (MWs). MWs play a pivotal role in communicating medical and scientific information to…

Considerations for the use of artificial intelligence in the creation of lay summaries of clinical trial results - Volume 34, Issue

The clinical research landscape is constantly evolving, as new regulations and innovations come together to help accelerate scientific discoveries and medical advances. A prominent example of this is the rapidly emerging technology of artificial…

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…

News from the EMA - Volume 32, Issue

Anuradha Alahari (section editor) EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo OPEN framework extended to a wider range of medicines Global regulators agree on way forward to adapt COVID-19 vaccines to…

55th EMWA Conference - Volume 32, Issue

The 55th EMWA Conference took place on May 9–13, 2023, in Prague. With more than 400 participants from across Europe and the world, it was a rousing success. Topics of workshops and presentations ranged from the latest in regulatory writing and…

The new value of clinical data in Europe - Volume 29, Issue

The EU’s new Medical Devices Regulation and In-vitro Diagnostic Device Regulation has integrated and reinforced the regulatory requirements for pre- and post-market clinical trials and positioned them as vital to ensuring the safety and performance…

From data to impact: Exploring the evolution of real-world evidence at the FDA - Volume 34, Issue

The healthcare industry has witnessed a significant shift towards the use of real-world data (RWD) and real-world evidence (RWE) in medical decision-making and treatment evaluation. This article explores the importance of RWE in healthcare…

Digital Communication - Volume 33, Issue

Section Editor: Nicole Bezuidenhout Traversing the social media landscape: Digital health communications in 2024 Author: Shannen Young Amidst a post-pandemic landscape marked by dis- and misinformation, new technologies, and platform shifts,…

From algorithms to insights: The role of medical writers in AI-enhanced real-world evidence - Volume 34, Issue

Real-world evidence (RWE) complements randomised controlled trials (RCTs) by assessing treatment effectiveness in diverse populations. Integrating artificial intelligence (AI) and machine learning (ML) enhances RWE by enabling predictive modelling,…

Lessons learnt from PETHEMA’s RWD research: A clinical perspective - Volume 34, Issue

PETHEMA (Programa Español de Tratamientos en Hematología, or, Spanish Program for Treatments in Haematology) a leading cooperative group in haematological research, has increasingly integrated real-world data (RWD) as a complement to traditional…

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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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