Medical Writing Trends in medical writing Trends in regulatory writing: A brief overview for aspiring medical writers

Volume 28, Issue 3 - Trends in medical writing

Trends in regulatory writing: A brief overview for aspiring medical writers

Abstract

The EU regulatory system is undergoing a major overhaul. Several new pieces of legislation are now in place to enforce harmonisation and transparency in clinical trials while ensuring data security and individual privacy. New and aspiring medical writers need to be aware of trends in the regulatory landscape to adapt to new requirements in technical documentation. This article is an overview of the evolving trends in EU regulations for medical devices (Medical Device Regulation and In-Vitro Device Regulation) and data compliance (General Data Protection Regulation and EMA Policy 0070), and the impact of artificial intelligence (AI) on the global medical writing market.

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Articles

Introduction
President's Message
EMWA News
Omics in silico and other trends in biomedical research: Impact on how and what we write
Catching the wave of lifestyle medicine
Artificial intelligence – will we be replaced by robots?
Now more than ever, scientists must speak up for science
When less is more: Medical writers as guardians of curated content
Predatory publishing – what medical communicators need to know
AMWA – EMWA – ISMPP Joint Position Statement on Predatory Publishing
How to combat medical misinformation with a sound content strategy
Subcontracting: Not for the faint of heart
Lay summaries and writing for patients: Where are we now and where are we going?
Clinical trial disclosure: Perspective from a medical writer for a contract research organisation
The 360° approach to authoring risk management plans
Trends in regulatory writing: A brief overview for aspiring medical writers
The medical writing landscape in China
News from the EMA
Regulatory Matters
Medical Communications and Writing for Patients
In the Bookstores
Getting Your Foot in the Door
Veterinary Medical Writing
Medical Devices
My First Medical Writing
Journal Watch
Good Writing Practice
Regulatory Public Disclosure
Out on Our Own

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Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Clare Chang

Barbara Grossman

Daniela Nakagawa

Joselita T. Salita

Petal Smart

Amy Whereat

Section Editors

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh / Stephen Gilliver

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Namrata Upadhyay

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Tiziana von Bruchhausen

Pharmacovigilance

Jennifer Clemens

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Jennifer Bell / Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk