Medical Writing Regulatory Writing Basics Out On Our Own

Volume 23, Issue 2 - Regulatory Writing Basics

Out On Our Own


Our gathering in Budapest last month was, as always, fun and this time a little different. We welcomed you to a new-look Freelance Business Forum (FBF) after polling you in February on what you hoped to gain from FBF attendance and your preferred meeting environment. Refreshments fuelled an informal atmosphere and, with experienced freelance colleagues in circulation, we were able to inject some dynamism and creativity into our discussions on common issues that affect us all. Between us, we conjured the FBF that you wanted. How do we know that? You told us so in a straw poll at the end of the meeting. We will try this format again, so next time, be sure to come along and join us at the Florence FBF in November 2014.


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  2. Some of the response to her book can also be found under Available from:,_Shoots_%26_Leaves
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  4. The Chicago manual of style. 16th ed. Chicago: University of Chicago Press; 2010.
  5. AMA Manual of Style: a guide for authors and editors. 10th ed. Oxford: Oxford University Press; 2007.
  6. de Looze S. Slash the Slash - or, The Art of Not Being Oblique. TWS 2001;10(4):89–93.
  7. What is online file storage? [2014 Feb]. Available from:
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  10. Baldwin C. Cloud storage for freelancers. Freelancing matters, issue 42 [2014 Feb 5]. Available from:



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

Member Login


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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

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Tiziana von Bruchhausen


Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk