Medical Writing Regulatory Writing Basics In the Bookstores
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Volume 23, Issue 2 - Regulatory Writing Basics

In the Bookstores

Abstract

Deadly Medicines and Organised Crime: How big pharma has corrupted healthcare by Peter Gøtzsche; Radcliffe Publishing, 2013. ISBN: 978-184619-884-7 (paperback). 24.99 GBP. 310 pages.

Mastering Scientific and Medical Writing: A Self-help Guide by Silvia M Rogers; Springer, 2014 (2nd edition). ISBN: 978-3-642-39445-4. 26.99 GBP. 116 pages.

References

  1. Jacobs A. In the bookstores: Bad Pharma. Medical Writing 2013;22(1):50–1.
  2. World Health Organization. The top 10 causes of death [updated 2013 Jul; cited 2013 Dec 10]. Available from: http://www.who.int/mediacentre/factsheets/fs310/en/index.html
  3. Mercola.com. Doctors are the third leading cause of death in the US, killing 225,000 people every year [2000 Jul 30; cited 2013 Dec 10]. Available from: http://articles.mercola.com/sites/articles/archive/2000/07/30/doctors-death-part-one.aspx
  4. Hall H. Death by medicine [2008 Jun 24; cited 2013 Dec 10]. Available from: http://www.sciencebasedmedicine.org/death-by-medicine/
  5. Jacobs A. Are big pharma like the mafia? [2013 Dec 10; cited 2013 Dec 10]. Available from: http://dianthus.co.uk/are-big-pharma-like-the-mafia
  6. Cancer Research UK. Long-term survival from once-deadly cancers doubles [2010 Jul 12; cited 2013 Dec 10]. Available from: http://www.cancerresearchuk.org/about-us/cancer-news/press-release/long-term-survival-from-once-deadly-cancers-doubles
  7. Jacobs A, Wager E. European Medical Writers Association (EMWA) guidelines on the role of medical writers in developing peer-reviewed publications. Curr Med Res Opin 2005;21(2):317–22.
  8. Ford ES, Ajani UA, Croft JB, Critchley JA, Labarthe DR, Kottke TE, et al. Explaining the decrease in U.S. deaths from coronary disease, 1980–2000. N Eng J Med 2007;356(23):2388–98.
  9. Mercola.com. Pulling back the curtain on the organized crime ring that is the pharmaceutical drug cartel [2013 Oct 16; cited 2013 Dec 10]. Available from: http://articles.mercola.com/sites/articles/archive/2013/10/16/drug-commercials-misleading.aspx
  10. Alliance for Natural Health. ANH-Intl exclusive: interview with Dr Peter Gotzsche, author of “Deadly Medicines and Organised Crime” [2013 Nov 27; cited 2013 Dec 10]. Available from: http://anh-europe.org/ANH-Intl+Exclusive+Interview+with+Dr+Peter+Gotzsche+author+of+Deadly+Medicines+and+Organised+Crime
  11. What Doctors Don't Tell You. Adverse reactions: light in the darkness [2013 Nov 29; cited 2013 Dec 10]. Available from: http://community.wddty.com/blogs/adverse_reactions/archive/2013/11/29/Light-in-the-darkness.aspx
  12. Ponsford D. What Doctors Don't Tell You – the magazine that freedom of speech campaigners want withdrawn from sale [2013 Oct 10; cited 2013 Dec 10]. Available from: http://www.pressgazette.co.uk/what-doctors-dont-tell-you-magazine-freedom-speech-campaigners-want-ban
  13. Drees B. A call to abandon the useless anachronism of the ‘define at first use’ rule for abbreviations. Medical Writing 2013;22(4):316.

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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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