Medical Writing Medical Communication Regulatory Matters

Volume 25, Issue 2 - Medical Communication

Regulatory Matters

Abstract

The growing need for drug safety documents

When I first started in regulatory writing (over a decade ago now, how time flies when you’re a medical writer), the types of document that I would be involved in were typically clinical study reports, investigator brochures, maybe protocols, and then later clinical summaries and overviews. Posts advertising for regulatory writers would usually mention these documents, which were also the focus of the EMWA training programme.

Download the full article

Search

Articles

Medical communication writers: Who are they and what do they do?
EMWA News
President's Message
Suggested reading in recent issues of European Science Editing
Medical affairs writing: A key role to relay medical information to everyone
Top ten questions about careers in MedComms
Staying ahead of the game in the changing arena of ethical medical communications - Viewpoint of a freelance medical writer
A PhD and medical writing: A good match
Writing for pharmaceutical or medical device companies: A survey of entry requirements, career paths, quality of life, and personal observations
Medical Gems
The request for proposal process: A brief overview for trainee medical writers
Winners of the Geoff Hall Scholarship Essay Competition
Abstracts from the EMWA Spring Conference Poster Session
News from the EMA
Journal Watch
In the Bookstores
The Webscout
Regulatory Matters
Lingua Franca and Beyond
Gained in Translation
Medical Writing Teaching
Profile - An Interview with Juliane Chaccour - Writing in Mozambique
Letter to the Editor
Out On Our Own

Member Login

Links

The Write Stuff Archive Contact Instructions for Authors Article Template (Word) Journal Policies

Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

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

AI/Automation

Jennifer Bell

Biotechnology

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

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

Adriana Rocha

Out on Our Own

Tiziana von Bruchhausen

Pharmacovigilance

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