Medical Writing Writing for Lay Audiences Legislation and the lay audience: Challenges of communicating benefit and risk in the light of new regulations

Volume 24, Issue 4 - Writing for Lay Audiences

Legislation and the lay audience: Challenges of communicating benefit and risk in the light of new regulations


There is a paradigm shift in the pharmaceutical industry and regulatory agencies towards transparency and an emphasis on the benefit-risk ratio of medicines. The recent changes in legislation surrounding clinical documentation have produced significant challenges for medical writers, who are now tasked with translating and explaining complex concepts for the lay audience. This article explains some of the challenges faced by medical writers in this new era.

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Writing for lay audiences
President's Message
Writing for lay audiences: A challenge for scientists
Patient education accessibility
Legislation and the lay audience: Challenges of communicating benefit and risk in the light of new regulations
Medical writing for two audiences – The RMP public summary
Layperson summaries of clinical trial results: Useful resources in the vacuum of regulatory guidance
Package leaflets for medication in the EU: The possibility of integrating patients’ perspectives in a regulated genre?
What do writers need to know about user testing?
Medical journalism: Another way to write about science
Elements of storytelling in medical journalism
A stroll through the medical blogosphere
Writing narrative style literature reviews
News from the EMA
Profile: An interview with Laura Carolina Collada Ali: On the peculiarities of working for independent research organisations
The Webscout
In the Bookstores
Regulatory Writing
Lingua Franca and Beyond
Gained in Translation
English Grammar and Style
Out On Our Own


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Editoral Board


Raquel Billiones


Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir


Jennifer Bell


Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News 

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Maddy Dyer


Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Adriana Rocha


Tiziana von Bruchhausen


Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk