| Description |
1 online resource |
| Physical Medium |
polychrome |
| Description |
text file |
| Note |
Title from PDF title page. |
| Bibliography |
Includes bibliographical references. |
| 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. |
| Funding |
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. |
| 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. |
| Local Note |
eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America |
| Subject |
Drug Design. |
|
Drug Evaluation -- standards. |
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Legislation, Drug. |
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Pharmaceutical Preparations -- supply & distribution. |
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Internationality. |
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Drug development.
|
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Drug development. |
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Drugs -- Testing -- Standards.
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Drugs -- Testing -- Standards. |
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Drugs -- Testing. |
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Drug approval -- Methods.
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Drug approval. |
| Genre/Form |
Congress.
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Electronic books.
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Methods (Music)
|
| Subject |
Medication. |
| Genre/Form |
Conference papers and proceedings.
|
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Conference papers and proceedings.
|
| Added Author |
Lustig, Tracy A., author.
|
|
Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation, issuing body.
|
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International Regulatory Harmonization Amid Globalization of Biomedical Research and Medical Product Development (Workshop) (2013 : Washington, D.C.)
|
| Other Form: |
Print version: International regulatory harmonization amid globalization of drug development. Washington, D.C. : National Academies Press, 2013 9780309284790 |
| ISBN |
9780309284790 |
|
0309284791 |
|
9780309284806 |
|
0309284805 |
|
