Medical Writing Regulatory Writing Basics Medical Communication

Volume 23, Issue 2 - Regulatory Writing Basics

Medical Communication


Dear all,

My first duty is to thank all of the new and aspiring medical writers who sent an entry to Head Office for the Geoff Hall Scholarship Award. The committee has awarded one scholarship this year, but we urge anyone who was not successful to please try again, if you are eligible. The title for next year's essay is: ‘Are Medical Writers Ghostwriters?’.

This year's essays certainly sparked some debate, and our decision was not easy. However, I am delighted and very privileged to be able to introduce you to the first winner of a Geoff Hall Scholarship: Menorca Chaturvedi. I had intended to write a little bit about her background and experience myself, but she sent me such a lovely letter that I thought it much more appropriate that she introduces herself. Her letter is below, followed by her winning entry.

Lisa Chamberlain James

Download the full article


  1. Venables H. The Frankenstein diaries. Viking; 1980.
  2. Stevenson G. 21st century novel: an investigation of graphic devices in literary fiction. The Publishing Lab, 30–31.
  3. Sharma S. How to become a competent medical writer? Perspect Clin Res 2010;1(1):33–7.
  4. Prioreschi P. A History of Medicine, Vol. III. Omaha, Horatius Press; 1998. pp. 182–211.
  5. Hook DH, Norman JM. The Haskell F. Norman library of science and medicine. San Francisco, Jeremy Norman & Co.; 1991. No. 424.
  6. Ghalioungui P. Magic and Medical Science in Ancient Egypt. London, Hodder and Stoughton; 1963. pp. xvi, 189, illus., 30s.
  7. Crandall S, Elson R, McLaughlin C. Managing and communicating information in a new era. Fam Med 1997;29:270–4.



Regulatory writing basics
Message from the President
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
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
The Light Stuff


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

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