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Regulatory Public Disclosure - Volume 32, Issue

Editorial Sam Hamilton (author and section editor) Medical Writing. 2023;32(3):91–95. https://doi.org/10.56012/hnnl8161 Clinical Data Publication (Policy 0070) relaunch Alison McIntosh (author) In preparation for the relaunch of EMA Clinical…

Pharmacovigilance - Volume 31, Issue

The Regulatory Expert Seminar session at the 2021 Spring EMWA Conference took us on an amazing journey through marketing authorisation applications from a regulator’s and medical writer’s perspective. One of the presentations focussed on the…

Profile: An interview with Laura Carolina Collada Ali: On the peculiarities of working for independent research organisations - Volume 24, Issue

Laura C Collada Ali wears different hats: she is a medical writer plus a medical translator, and has extensive experience delivering multilingual authoring and translation services across a wide range of independent research organisations. She is a…

Peer review of a clinical trial protocol: Practical tips for regulatory medical writers, clinicians, and clinical scientists - Volume 32, Issue

Protocol development is a critical milestone in the clinical drug development process for all pharmaceutical companies conducting clinical trials. A regulatory medical writer (RMW) plays a crucial role in the protocol development and peer review…

Foreword from the European Commission - Volume 31, Issue

Already 1 year has passed since the date of application of the new Medical Devices Regulation (EU) 2017/745 (MDR), replacing the previous Directives 90/385/EEC and 93/42/EEC from 26 May 2021, while for the new In Vitro Diagnostic Medical Devices…

The Lay Protocol Synopsis: Requirements and feasibility - Volume 32, Issue

The EU Regulation 536/2014 included a requirement for companies to produce a Protocol Synopsis with a recommendation for a version in lay language. This requirement stated, among other things, a maximum length of two pages. This article outlines the…

Model-informed drug development in rare diseases - Volume 34, Issue

Model-informed drug development (MIDD) approaches maximise and connect information obtained on a drug during development, allowing better characterisation of its risk: benefit profile. MIDD is especially useful for rare diseases with few patients to…

The freelance medical writer and the medical writing agency: A symbiotic relationship - Volume 32, Issue

The medical writing industry is evolving. With a growing demand for competent and experienced medical writers in both the product industry (pharmaceutical, biotechnology-related, and medical technology-related) and service providers (clinical…

News from the EMA - Volume 29, Issue

September 14, 2020 – The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its workplan which sets actions to be delivered in 2020–2021. With the European Medicines Regulatory Network focused on the…

Outgoing President's Message - Volume 34, Issue

Passing the torch: Reflections on my tenure as president  Medical Writing. 2025;34(2):8. https://doi.org/10.56012/ohoz5167

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Scope

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.

Medical Writing is listed in the following indexes:

Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Brooks Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir

AI/Automation

Jennifer Bell

Biotechnology

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News 

Adriana Rocha

Freelancing

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Pablo Izquierdo / Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Maddy Dyer

Publications

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Tiziana von Bruchhausen

Pharmacovigilance

Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Jeff Blair / Luiza Ventura

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk