Medical Writing Regulatory Writing Basics

Volume 23, Issue 2 - Regulatory Writing Basics

June 2014

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Regulatory writing basics

President's Message

Message from the President

Feature Articles

A guide to pre-approval regulatory documents

Effective authoring of clinical study reports: A companion guide

The clinical study protocol and medical writing: A good fit?

The Investigator's Brochure: A multidisciplinary document

An overview of the Common Technical Document (CTD) regulatory dossier

Good clinical practice (GCP): A universal call for ethics in biomedical research

Adverse event reporting: A brief overview of MedDRA

The approval process of medicines in Europe

Recommended procedures for retracting articles: Inadequate and patchily applied? Analysis of a recent article in PLoS One

The needs assessment in continuing medical education

Origin and development of English for Medical Purposes. Part II: Research on spoken medical English

Did minor flaws in a new drug reveal major flaws in company publication practices?

What every medical writer needs to know

Profile: An interview with Laura McMahon on the role of clinical research coordinators in Italy

Regular Sections

In the Bookstores

Journal Watch: Dedicated medical writing rotation for pharmacists, publication of drug industry funded research, and evidence-based medicine for clinical decision making

Regulatory Writing: The essence of regulatory writing as defined by its jargon

Medical Communication

News from the EMA

English Grammar and Style: Points of view

The Webscout

Gained in Translation: Science at the multilingual crossroads

Out On Our Own

Out On Our Own

The Light Stuff

The Light Stuff



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


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


Raquel Billiones


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


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