Medical Writing Medical Writing Around the World Medical writing in the Russian Federation: Promises and pitfalls

Volume 22, Issue 2 - Medical Writing Around the World

Medical writing in the Russian Federation: Promises and pitfalls

Abstract

More and more clinical studies are taking place in Russia, making it an attractive market for medical writing. In 2011, the Ministry of Healthcare of the Russian Federation approved over 550 new clinical studies of all types, a 16% increase over the previous year. Currently, the Russian government is making huge investments in its infrastructure for drug development. Demand for medical writing is high in the rapidly growing sector of biotechnology in Russia. Because there are some differences in local requirements compared to the EU or USA, many specific regulatory aspects have to be considered by medical writers in Russia.

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References

  1. Russia, The registry of Approved Clinical Trials [Реестр выданных разрешений на проведение клинических исследований лекарственных препаратов] [homepage on the Internet]. c2011 [cited 2013 February 16]. Available from: http://grls.rosminzdrav.ru/CIPermitionReg.aspx
  2. Russia, National Standard of the Russian Federation. GOST R 52379-2005 ‘Good Clinical Practice’ [ГОСТ Р 52379-2005 ‘Качественна клиническая практика’]. c2005 [cited 2013 March 14]. Available from: State Law Publisher.
  3. Russia, Federal Law #61 on Circulation of Medicines [Федеральный закон от 12.04.2010 года № 61-ФЗ ‘Об обращении лекарственных средств’] c2010 April 12 [cited 2013 March 14]. Available from: State Law Publisher.
  4. Russia, Operating Instructions ‘Execution of Good Bioequivalence Studies of Drugs’ [Методические указания «Оценка биоэквивалентности лекарственных средств»], c2008 [cited 2013 March 14]. Available from: State Law Publisher.
  5. World Health Organization. Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. c2005 [cited 2013 March 14]. Available from: http://www.who.int/medicines/services/expertcommittees/pharmprep/QAS04_093Rev4_final.pdf
  6. Health Canada. Comparative bioavailability standards: formulations used for systemic effects. Available from: http://www.learnandconfirm.ca/resources/gd_standards_ld_normes-eng.pdf
  7. . OCT attending and presenting at the Adam Smith Conference in Moscow [homepage on the Internet]. c2012 [cited 2013 March 14]. Available from: http://www.oct-clinicalstudies.com/?q=content/oct-attending-and-presenting-adam-smith-conference-moscow

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Medical writing in the Russian Federation: Promises and pitfalls
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Mentorship in EMWA: A perspective
In the Bookstores
The Webscout
Regulatory Writing
English Grammar and Style
Medical Journalism
Medical Communication
The Light Stuff
Out On Our Own

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