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.
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...
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| Format: | Conference Proceeding eBook |
| Language: | English |
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Washington, D.C. :
National Academies Press,
[2013]
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Table of 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.