Quality of Regulatory Decision-Making Practices: Issues Facing Companies and Agencies

Therapeutic Innovation & Regulatory Science
Magdalena BujarStuart Walker

Abstract

The science of decision making is well established, although in reality it is a mixture of science and art. What is currently lacking is research into decision making in medicines research and development. The aims of this study were to determine the current decision-making practices and methodologies for measuring the quality of the decision making and the barriers and solutions for making quality decisions within pharmaceutical companies and regulatory agencies. Two analogous questionnaires were developed for use in this study. Fourteen agencies and 25 companies were asked to complete the questionnaire, assessing their decision making for submitting or approving a new drug application. The 68% and 71% response rate from companies and agencies, respectively, suggests interest in this topic, but the area is largely unexplored within the pharmaceutical environment. Moreover, all companies and 90% of the agencies believed that decision making at their organizations could be improved. Although both stakeholders have, to some extent, already implemented frameworks and various methodologies, these are often informal and unsystematic. Challenges remain and there is a need to change the organizational culture by increasing the awarene...Continue Reading

References

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Aug 22, 2013·Clinical Pharmacology and Therapeutics·L LibertiR Peterson
Jan 30, 2015·Pharmacoepidemiology and Drug Safety·Ronan DonelanSam Salek
Jun 13, 2015·Nature Reviews. Drug Discovery·Katarzyna SmietanaMartin Møller
Jan 1, 2015·Therapeutic Innovation & Regulatory Science·Stuart WalkerSam Salek
Nov 1, 2014·Therapeutic Innovation & Regulatory Science·Michele MarangiLuca Pani
Jan 1, 2013·Therapeutic Innovation & Regulatory Science·Todd D McIntyreJames J DiBiasi

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Citations

Mar 6, 2019·Therapeutic Innovation & Regulatory Science·Magdalena BujarSam Salek
Sep 4, 2017·Annals of the Rheumatic Diseases·Jonathan KayUNKNOWN Task Force on the Use of Biosimilars to Treat Rheumatological Diseases

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