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

Per Spindler; Karin Friis Bach; Merete Schmiegelow; Nicola Bedlington; Hans-Georg Eichler

doi:10.1177/2168479015599810

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

Bidragets oversatte titel: Innovation af biomedicinske produkter - forsknings- og uddannelsesmæssige perspektiver for den akademiske disciplin regulatory science.

Per Spindler, Karin Friis Bach, Merete Schmiegelow, Nicola Bedlington, Hans-Georg Eichler

LUKKET: Biopeople

5 Citationer (Scopus)

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.

Bidragets oversatte titel	Innovation af biomedicinske produkter - forsknings- og uddannelsesmæssige perspektiver for den akademiske disciplin regulatory science.
Originalsprog	Engelsk
Tidsskrift	Therapeutic Innovation & Regulatory Science
Vol/bind	50
Udgave nummer	1
Sider (fra-til)	44-48
ISSN	2168-4790
DOI	https://doi.org/10.1177/2168479015599810
Status	Udgivet - 1 jan. 2016

Adgang til dokumentet

10.1177/2168479015599810

https://journals.sagepub.com/doi/pdf/10.1177/2168479015599810

Citationsformater

@article{661cea9d95d34a4cb02426eb4ea91b5d,

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

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.",

author = "Per Spindler and Bach, {Karin Friis} and Merete Schmiegelow and Nicola Bedlington and Hans-Georg Eichler",

year = "2016",

month = jan,

day = "1",

doi = "10.1177/2168479015599810",

language = "English",

volume = "50",

pages = "44--48",

journal = "Therapeutic Innovation & Regulatory Science",

issn = "2168-4790",

publisher = "SAGE Publications",

number = "1",

}

TY - JOUR

T1 - Innovation of Medical Products

T2 - The Evolution of Regulatory Science, Research, and Education

AU - Spindler, Per

AU - Bach, Karin Friis

AU - Schmiegelow, Merete

AU - Bedlington, Nicola

AU - Eichler, Hans-Georg

PY - 2016/1/1

Y1 - 2016/1/1

N2 - 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.

AB - 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.

U2 - 10.1177/2168479015599810

DO - 10.1177/2168479015599810

M3 - Journal article

SN - 2168-4790

VL - 50

SP - 44

EP - 48

JO - Therapeutic Innovation & Regulatory Science

JF - Therapeutic Innovation & Regulatory Science

IS - 1

ER -