Medical Writing Regulatory Writing Basics The Webscout
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Volume 23, Issue 2 - Regulatory Writing Basics

The Webscout

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Abstract

What happens pre-approval?

The theme of this issue made me wonder what it is that happens before approval of a new medication. Of course, it is clinical development, notably phase II and phase III studies. But many years have already passed before a drug reaches this particular development phase and many drugs have failed on the way to that point. Only 1 out of 5000 to 10 000 development compounds makes it to the market and this process can take up to 15 years.

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Articles

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 examining the fates of retracted articles
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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Editoral Board

Editor-in-Chief:

Co-Editor:

Editorial Manager

  • Victoria White (Tampa, Florida, USA)
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Associate Editors:

Section Editors:

Ad-hoc Editors:

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

Editor Emeritus: