Medical Writing Regulatory Writing Basics What every medical writer needs to know

Volume 23, Issue 2 - Regulatory Writing Basics

What every medical writer needs to know


A medical writer is never done with learning. In the fast-paced world of online communications, learning means getting involved in the digital environment and using tools like social media, websites, and blogs to enhance your online presence and develop your career. Health Writer Hub, a new global community for health and medical writers offering tips and advice focused on digital communications, getting started, freelancing, finding employment, and more, can be useful to achieve these goals.

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  1. Infographic: 24 hours on the Internet. Digital Buzz Blog [cited 2012 Mar 13]. Available from:
  2. Smith P. Content, commerce, email, print and mobile: 24 statistics on the changing digital economy. The Media Briefing [cited 2013 Jul 4]. Available from:
  3. Chang S. The future of content: upcoming trends in 2014. The Moz Blog [cited 2013 Dec 9]. 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

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

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