REGULATORY SCIENCE: MODERN TRENDS IN SCIENCE AND EDUCATION FOR PHARMACEUTICAL PRODUCTS

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Abstract


This article reviews modern trends in development of new instruments, standards and approaches to drugs safety, efficacy and quality assessment in USA and EU that can be called by unique term — «regulatory science» which is a new concept for Russian Federation. New education programs (curricula) developed by USA and EU universities within last 3 years are reviewed. These programs were designed in order to build workforce capable to utilize science approach for drug regulation. The principal mechanisms for financing research in regulatory science used by Food and Drug Administration are analyzed. There are no such science and relevant researches in Russian Federation despite the high demand as well as needs for the system for higher education and life-long learning education of specialists for regulatory affairs (or compliance).

 


About the authors

V. V. Beregovykh

The First Moscow State Medical University named after I.M. Sechenov, Russian Federation

Author for correspondence.
Email: osipova-mma@bk.ru

Russian Federation PhD, Corresponding Member of Russian Academy of Medical Sciences, Head of a Chair of Industrial Pharmacy, State Budget Educational Institution of Higher Professional Education First Moscow State Medical University named after I.M. Sechenov, Ministry of Health, Russian Academy of Medical Sciences Address: 119991, Moscow, Trubetskaya str. 8, bldg. 2; Tel.: (495) 698-52-59

N. V. Pyatigorskaya

The First Moscow State Medical University named after I.M. Sechenov, Russian Federation

Email: osipova-mma@bk.ru

Russian Federation PhD, Professor, Chair of Industrial Pharmacy, State Budget Educational Institution of Higher Professional Education First Moscow State Medical University named after I.M. Sechenov, Ministry of Health, Russian Academy of Medical Sciences Address: 119991, Moscow, Trubetskaya str. 8, bldg. 2

Zh. I. Aladysheva

The First Moscow State Medical University named after I.M. Sechenov, Russian Federation

Email: osipova-mma@bk.ru

Russian Federation Candidate of Medical Sciences, Associate Professor, Chair of Industrial Pharmacy, State Budget Educational Institution of Higher Professional Education First Moscow State Medical University named after I.M. Sechenov, Ministry of Health, Russian Academy of Medical Sciences Address: 119991, Moscow, Trubetskaya str. 8, bldg. 2

References

  1. FDA. Advancing regulatory science. Available at: http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/default.htm (accessed 27.11.2012)
  2. FDA Science Board. 2007. FDA Science and Mission at Risk. Rockville, MD: Report of the Subcommittee on Science and Technology.
  3. RSI. Institute for regulatory science. Available at: http://www.nars.org/whatis.html (accessed 27.11.2012)
  4. Olson S., Claiborn A.B. Strengthening a workforce for innovative regulatory science. Workshop Summary. The National Academies Press. 2012. 103 p.
  5. EMA (European Medicines Agency). 2010. The European Medicines Agency Road Map to 2015: The Agency’s Contribution to Science, Medicines, Health (adopted by Agency’s Management Board on 16 December 2010). London: EMA. 21 p.
  6. University of South California.MS Regulatory Science-Required Coursework. Available at: http://regulatory.usc.edu/Masters.htm (accessed 27.11.2012)
  7. Pharmatrain. Available at: http://www.pharmatrain.eu/index.php (accessed 27.11.2012)
  8. Purdue University. Department of industrial and physical pharmacy. Strategic plan: 2010–2015 (revision December 2011). Available at: http://www.ipph.purdue.edu/aboutus/strategic_plan.pdf (accessed 27.11.2012)
  9. FDA. Fellowship, Internship, Graduate and Faculty programs.: http://www.fda.gov/AboutFDA/WorkingatFDA/FellowshipInternshipGraduateFacultyPrograms/ (accessed 27.11.2012)
  10. MIT. Center for Biomedical Innovation. NEWGIGS Initiative. Available at: http://cbi.mit.edu/research-overview/newdigs/ (accessed 27.11.2012)
  11. The NIH Common Fund. Office of strategic coordination. Regulatory science. Available at: http://commonfund.nih.gov/regulatoryscience/
  12. Federal'nyi zakon ot 22.04.2010 g. № 61-FZ «Ob obrashchenii lekarstvennykh sredstv» (deistvuyushchaya redaktsiya) [The Federal Law dated 22.04.2010, № 61-FZ "On Circulation of Medicines" (current version)].
  13. Federal'naya tselevaya programma «Razvitie farmatsevticheskoi i meditsinskoi promyshlennosti Rossiiskoi Federatsii na period do 2020 g. i dal'neishuyu perspektivu», utverzhdena Postanovlenie Pravitel'stva Rossiiskoi Federatsii ot 17.02.2011 g. № 91 [The Federal Target Program "Development of the Pharmaceutical and Medical Industry of the Russian Federation for the period up to 2020 and beyond", approved by Resolution of the Government of the Russian Federation dated 17.02.2011 № 91].
  14. Federal'nyi Gosudarstvennyi obrazovatel'nyi standart vysshego professional'nogo obrazovaniya po napravleniyu podgotovki (spetsial'nosti) 060301 Farmatsiya (kvalifikatsiya (stepen') «Spetsialist»). Utverzhden prikazom Ministerstva obrazovaniya i nauki Rossiiskoi Federatsii ot 17.01.2011 g. № 38 [The federal state educational standards of higher education in the direction of training (specialty) 060 301 Pharmacy (qualification (degree) "Specialist"). Approved by the Ministry of Education and Science of the Russian Federation dated17.01.2011, № 38].
  15. Gosudarstvennaya programma Rossiiskoi Federatsii «Razvitie farmatsevticheskoi i meditsinskoi promyshlennosti na 2012–2020 gg.», utverzhdena rasporyazheniem Pravitel'stva Rossiiskoi Federatsii ot 03.11.2012 g № 2057-r [State program of the Russian Federation "Development of pharmaceutical and medical industry for 2012-2020.", Approved by the Federal Government dated 03.11.2012 № 2057-r].
  16. Gosudarstvennaya programma Rossiiskoi Federatsii «Razvitie zdravookhraneniya». Proekt (State program of the Russian Federation "Development of health care." Project). Available at: http://www.rosminzdrav.ru/reception/projects/0 (accessed 27.11.2012)
  17. Ministerstvo ekonomicheskogo razvitiya Rossiiskoi Federatsii. Razvitie chastno-gosudarstvennogo partnerstva v Rossiiskoi Federatsi (The Ministry of Economic Development. Development of public-private partnership in the Russian Federation). Available at: http://www.economy.gov.ru/minec/activity/sections/investmentPolicy/privgovpartnerdev/ (accessed 27.11.2012)

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