The Role of Pharmacoepidemiology in Regulatory Agencies

Gerald J Dal Pan; Peter Arlett

doi:10.1002/9781119959946.ch8

The Role of Pharmacoepidemiology in Regulatory Agencies

Gerald J Dal Pan, Peter Arlett

Research output: Chapter in Book/Report/Conference proceeding › Chapter

2 Scopus citations

Abstract

The data sources and methods that underlie the discipline of pharmacoepidemiology have expanded greatly over the past several decades. This growth has involved academia, industry, and regulatory agencies. For drug regulatory agencies, pharmacoepidemiology is a core scientific discipline. Three key issues are highlighted that are of particular importance to drug regulators: using pharmacoepidemiology throughout a product's lifecycle; developing approaches to synthesize data from multiple sources; and building capacity in the field of pharmacoepidemiology.

Original language	English (US)
Title of host publication	Pharmacoepidemiology, Fifth Edition
Publisher	Wiley-Blackwell
Pages	107-116
Number of pages	10
ISBN (Print)	0470654759, 9780470654750
DOIs	https://doi.org/10.1002/9781119959946.ch8
State	Published - Jan 3 2012
Externally published	Yes

Keywords

Drug safety
Evidence-based decision making
Regulatory agency

ASJC Scopus subject areas

Medicine(all)
Pharmacology, Toxicology and Pharmaceutics(all)

Access to Document

10.1002/9781119959946.ch8

Cite this

@inbook{1424104265b74f55ad19395abae2d619,

title = "The Role of Pharmacoepidemiology in Regulatory Agencies",

abstract = "The data sources and methods that underlie the discipline of pharmacoepidemiology have expanded greatly over the past several decades. This growth has involved academia, industry, and regulatory agencies. For drug regulatory agencies, pharmacoepidemiology is a core scientific discipline. Three key issues are highlighted that are of particular importance to drug regulators: using pharmacoepidemiology throughout a product's lifecycle; developing approaches to synthesize data from multiple sources; and building capacity in the field of pharmacoepidemiology.",

keywords = "Drug safety, Evidence-based decision making, Regulatory agency",

author = "Pan, {Gerald J Dal} and Peter Arlett",

year = "2012",

month = jan,

day = "3",

doi = "10.1002/9781119959946.ch8",

language = "English (US)",

isbn = "0470654759",

pages = "107--116",

booktitle = "Pharmacoepidemiology, Fifth Edition",

publisher = "Wiley-Blackwell",

}

TY - CHAP

T1 - The Role of Pharmacoepidemiology in Regulatory Agencies

AU - Pan, Gerald J Dal

AU - Arlett, Peter

PY - 2012/1/3

Y1 - 2012/1/3

N2 - The data sources and methods that underlie the discipline of pharmacoepidemiology have expanded greatly over the past several decades. This growth has involved academia, industry, and regulatory agencies. For drug regulatory agencies, pharmacoepidemiology is a core scientific discipline. Three key issues are highlighted that are of particular importance to drug regulators: using pharmacoepidemiology throughout a product's lifecycle; developing approaches to synthesize data from multiple sources; and building capacity in the field of pharmacoepidemiology.

AB - The data sources and methods that underlie the discipline of pharmacoepidemiology have expanded greatly over the past several decades. This growth has involved academia, industry, and regulatory agencies. For drug regulatory agencies, pharmacoepidemiology is a core scientific discipline. Three key issues are highlighted that are of particular importance to drug regulators: using pharmacoepidemiology throughout a product's lifecycle; developing approaches to synthesize data from multiple sources; and building capacity in the field of pharmacoepidemiology.

KW - Drug safety

KW - Evidence-based decision making

KW - Regulatory agency

UR - http://www.scopus.com/inward/record.url?scp=84883152757&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84883152757&partnerID=8YFLogxK

U2 - 10.1002/9781119959946.ch8

DO - 10.1002/9781119959946.ch8

M3 - Chapter

AN - SCOPUS:84883152757

SN - 0470654759

SN - 9780470654750

SP - 107

EP - 116

BT - Pharmacoepidemiology, Fifth Edition

PB - Wiley-Blackwell

ER -

The Role of Pharmacoepidemiology in Regulatory Agencies

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this