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

Volume 22, Issue 4 - Good Pharma

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

Author: Susanne Goebel-Lauth

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.

Keywords: Regulatory intelligence, good regulatory practice
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References

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