Medical Writing Medical Writing Around the World Medical writing in the Russian Federation: Promises and pitfalls
mew-150pxjpg

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.

Download the full article

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

Search

Articles

Medical writing around the world
Message from the President
The yin and yang of medical writing in China
The changing face of medical writing in India
Medical writing in India at a crossroads
Medical writing in the Middle East
Medical writing in Finland
On the western edge of Europe – medical writing in Portugal
Announcing AERTeM, the Spanish Association of Medical Writers
From editors abroad into businesswomen back in Brazil
Science writing workshops for AIDS vaccine researchers in Africa
Medical postcard from Australia, the world's largest island
Teaching English for Medical Academic Purposes at the Faculty of Medicine in Belgrade, Serbia
Regulatory medical writing in Switzerland
Medical writing in the Russian Federation: Promises and pitfalls
Report on the EMA Workshop on clinical trial data and transparency
Potential implications of wider data transparency in medical communications
The need for registration of preclinical studies
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

Member Login

Links

The Write Stuff Archive Contact Instructions for Authors Feature Article Template (Word) Journal Policies

Editoral Board

Editor-in-Chief:

Co-Editor:

Managing Editor

show all +

Associate Editors:

Section Editors:

Ad-hoc Editors:

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

Editor Emeritus: