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Volume 23, Issue 2 - Regulatory Writing Basics

Medical Communication

Authors: Lisa Chamberlain James, Menorca Chaturvedi

Abstract

Dear all,

My first duty is to thank all of the new and aspiring medical writers who sent an entry to Head Office for the Geoff Hall Scholarship Award. The committee has awarded one scholarship this year, but we urge anyone who was not successful to please try again, if you are eligible. The title for next year's essay is: ‘Are Medical Writers Ghostwriters?’.

This year's essays certainly sparked some debate, and our decision was not easy. However, I am delighted and very privileged to be able to introduce you to the first winner of a Geoff Hall Scholarship: Menorca Chaturvedi. I had intended to write a little bit about her background and experience myself, but she sent me such a lovely letter that I thought it much more appropriate that she introduces herself. Her letter is below, followed by her winning entry.

Lisa Chamberlain James
lisa@trilogywriting.com

References

  1. Venables H. The Frankenstein diaries. Viking; 1980.
  2. Stevenson G. 21st century novel: an investigation of graphic devices in literary fiction. The Publishing Lab, 30–31.
  3. Sharma S. How to become a competent medical writer? Perspect Clin Res 2010;1(1):33–7.
  4. Prioreschi P. A History of Medicine, Vol. III. Omaha, Horatius Press; 1998. pp. 182–211.
  5. Hook DH, Norman JM. The Haskell F. Norman library of science and medicine. San Francisco, Jeremy Norman & Co.; 1991. No. 424.
  6. Ghalioungui P. Magic and Medical Science in Ancient Egypt. London, Hodder and Stoughton; 1963. pp. xvi, 189, illus., 30s.
  7. Crandall S, Elson R, McLaughlin C. Managing and communicating information in a new era. Fam Med 1997;29:270–4.

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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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