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

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

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Raquel Billiones

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Evguenia Alechine

Jonathan Pitt

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Victoria White

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Alicia Waltman

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Anuradha Alahari

Jennifer Bell

Clare Chang

Barbara Grossman

Joselita T. Salita

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Aurélie Gobet / Paolo Rega

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Raquel Billiones

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Wendy Kingdom / Amy Whereat

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Alison McIntosh / Stephen Gilliver

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Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

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Lisa Chamberlain-James

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Namrata Upadhyay

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Evguenia Alechine

My First Medical Writing

Anuradha Alahari

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Laura Kehoe

Out on Our Own

Jennifer Clemens

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Sam Hamilton

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Claire Gudex

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Kimi Uegaki

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Karim Montasser

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Elise Langdon-Neuner

Phil Leventhal

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Chris Monk