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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  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.
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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

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  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

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