International Regulatory Harmonization Amid Globalization of Drug Development
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.
- 2012 the National Academy of Sciences.
- Book Quality:
- National Academies Press
- Date of Addition:
- Medicine, Nonfiction, Technology,
- Usage Restrictions:
- This is a copyrighted book.
Choosing a Book Format
EPUB is the standard publishing format used by many e-book readers including iBooks, Easy Reader, VoiceDream Reader, etc. This is the most popular and widely used format.
DAISY format is used by GoRead, Read2Go and most Kurzweil devices.
Audio (MP3) format is used by audio only devices, such as iPod.
Braille format is used by Braille output devices.
DAISY Audio format works on DAISY compatible players such as Victor Reader Stream.
Accessible Word format can be unzipped and opened in any tool that supports .docx files.