Journal Article
. 2016 Jan; 50(1):44-48.
doi: 10.1177/2168479015599810.

Innovation of Medical Products: The Evolution of Regulatory Science, Research, and Education

Per Spindler 1 Karin F Bach 1 Merete Schmiegelow 2 Nicola Bedlington 3 Hans-Georg Eichler 4 
Affiliations
  • PMID: 30236007
  •     2 citations

Abstract

We present a commentary on the international aspects of the evolution of regulatory science as a multidisciplinary, multistakeholder academic discipline of education and applied research emphasizing the need for seamless interaction between stakeholders such as regulatory authorities, the pharmaceutical industry, universities, payers, and patient organizations. Regulatory science is the science of developing new tools, standards, and approaches to evaluate the efficacy, safety, quality, and performance of medical products in order to assess benefit/risk and facilitate a sound and transparent regulatory decision making throughout development and life cycle management.

Keywords: academia; education; partnerships; patient organizations; pharmaceutical industry; regulatory authorities; regulatory research; regulatory science.

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