Medical Writing Regulatory Writing Basics News from the EMA

Volume 23, Issue 2 - Regulatory Writing Basics

News from the EMA


The articles included in this section are a selection from the EMA's news and press release archive for December 2013 – February 2014.

More information on the work of the EMA can be found on its website:


  1. See Arr Oh. Why aren't correction articles free? Just Like Cooking (blog); 2014 Jan 31 [cited 2014 Feb 7]. Available from:
  2. Oransky I. Should all correction notices be open access? Retraction Watch; 2014 Feb 4 [cited 2014 Feb 7]. Available from:
  3. Wager E, Barbour V, Yentis S, Kleinert S; On behalf of COPE Council. Retractions: guidance from the Committee on Publication Ethics (COPE). COPE; 2009 Sep [cited 2014 Feb 7]. 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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