Coverart for item
The Resource International regulatory harmonization amid globalization of drug development : workshop summary, Victoria Weisfeld and Tracy A. Lustig, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies

International regulatory harmonization amid globalization of drug development : workshop summary, Victoria Weisfeld and Tracy A. Lustig, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies

Label
International regulatory harmonization amid globalization of drug development : workshop summary
Title
International regulatory harmonization amid globalization of drug development
Title remainder
workshop summary
Statement of responsibility
Victoria Weisfeld and Tracy A. Lustig, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies
Creator
Contributor
Author
Issuing body
Subject
Genre
Language
eng
Summary
The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products and technologies. Increasingly, research on the safety and effectiveness of new drugs is being conducted in countries with little experience in regulation of medical product development. Demand has been increasing for globally harmonized, science-based standards for the development and evaluation of the safety, quality, and efficacy of medical products. Consistency of such standards could improve the efficiency and clarity of the drug development and evaluation process and, ultimately, promote and enhance product quality and the public health. To explore the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development, and Translation hosted a workshop on February 13-14, 2013. Discussions at the workshop helped identify principles, potential approaches, and strategies to advance the development or evolution of more harmonized regulatory standards. This document summarizes the workshop
Member of
Cataloging source
NLM
http://library.link/vocab/creatorName
Weisfeld, Victoria D
Dewey number
615.1/9
Funding information
This activity was supported by contracts between the National Academy of Sciences and the Department of Health and Human Services (HHSN26300023 [Under Base #HHSN263201200074I] and Contract No. N01-OD-4-2139 TO #276; HHSF22301026T [Under Base #HHSF223200810020I]), AbbVie Inc., American Diabetes Association, American Society for Microbiology, Amgen Inc., Association of American Medical Colleges, AstraZeneca, Bristol-Myers Squibb, Burroughs Wellcome Fund, Celtic Therapeutics, LLLP, Critical Path Institute, Doris Duke Charitable Foundation, Eli Lilly and Company, FasterCures, Friends of Cancer Research, GlaxoSmithKline, Johnson & Johnson, March of Dimes Foundation, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Pfizer Inc., and Sanofi. The views presented in this publication do not necessarily reflect the views of the organizations or agencies that provided support for the activity.
Index
no index present
Language note
English
LC call number
RM301.25
LC item number
.W45 2013
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
  • technical reports
NLM call number
  • 2014 E-685
  • QV 745
http://library.link/vocab/relatedWorkOrContributorDate
2013
http://library.link/vocab/relatedWorkOrContributorName
  • Lustig, Tracy A.
  • Institute of Medicine (U.S.)
  • International Regulatory Harmonization Amid Globalization of Biomedical Research and Medical Product Development (Workshop)
http://library.link/vocab/subjectName
  • Drug development
  • Drugs
  • Drug approval
  • Drug Design
  • Drug Evaluation
  • Internationality
  • Legislation, Drug
  • Pharmaceutical Preparations
  • MEDICAL
  • Drug approval
  • Drug development
  • Drugs
Label
International regulatory harmonization amid globalization of drug development : workshop summary, Victoria Weisfeld and Tracy A. Lustig, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies
Instantiates
Publication
Note
Title from PDF title page
Bibliography note
Includes bibliographical references
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
Introduction -- Principles and definitional considerations -- Overview of the current global regulatory landscape -- Areas of need for harmonized standards and barriers to progress in addressing the gaps -- Characteristics of harmonized regulations and regulatory structures -- Finding solutions: options and systemic approaches -- Tactics and strategies for a way forward
Control code
862117649
Dimensions
unknown
Extent
1 online resource
Form of item
online
Isbn
9780309284790
Media category
computer
Media MARC source
rdamedia
Media type code
c
Specific material designation
remote
System control number
(OCoLC)862117649
Label
International regulatory harmonization amid globalization of drug development : workshop summary, Victoria Weisfeld and Tracy A. Lustig, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies
Publication
Note
Title from PDF title page
Bibliography note
Includes bibliographical references
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
Introduction -- Principles and definitional considerations -- Overview of the current global regulatory landscape -- Areas of need for harmonized standards and barriers to progress in addressing the gaps -- Characteristics of harmonized regulations and regulatory structures -- Finding solutions: options and systemic approaches -- Tactics and strategies for a way forward
Control code
862117649
Dimensions
unknown
Extent
1 online resource
Form of item
online
Isbn
9780309284790
Media category
computer
Media MARC source
rdamedia
Media type code
c
Specific material designation
remote
System control number
(OCoLC)862117649

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