Medical Writing Regulatory Writing Basics

Volume 23, Issue 2 - Regulatory Writing Basics

June 2014


Regulatory writing basics

President's Message

Message from the President

Feature Articles

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

Regular Sections

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

Out On Our Own

The Light Stuff

The Light Stuff


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Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.

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Associate Editors:

Section Editors:

Ad-hoc Editors:

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

Editor Emeritus: