Medical Writing Good Pharma Good regulatory practice and the role(s) of a regulatory affairs professional
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Volume 22, Issue 4 - Good Pharma

Good regulatory practice and the role(s) of a regulatory affairs professional

Abstract

Good Regulatory Practice is a regulatory affairs quality standard that is based on trained people who understand their professional role and work in an environment that follows standards and processes. This article illustrates the diversity of roles represented by a regulatory affairs professional and explains the importance of focused training of personnel, and of generating departmental regulatory intelligence. Good Regulatory Practice is a prerequisite for achieving an optimal balance between regulatory requirements, anticipated target profile, and time to market.

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References

  1. Hägglöf I, Holmgren A. Roles and responsibilities of regulatory authority and company. In: Hill RG, Rang HP, editors. Drug discovery and development. 1st ed. London: Churchill Livingston; 2006. 281–97.
  2. European Industrial Pharmacist Group. Guide to Good Regulatory Practice 2008. Available from: http://www.eipg.eu/records/GRP%20commun%20CLEAN%20komm%20US_150408.pdf
  3. Alexio F. European Focus Portugal – guide to good regulatory practice. Regulatory Rapporteur 2005(May):31–34.
  4. Lassoff P. The hub of the wheel. Pharmaceutical Executive 2007 Feb–Mar. Available from: http://www.topra.org/sites/default/files/Hub_of_the_Wheel_-_TOPRA.pdf
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  7. American Society for Cell Biology. San Francisco Declaration on Research Assessment. 2013 [cited 2013 Sept 21] Available from: http://am.ascb.org/dora/.

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