International regulatory harmonization amid globalization of drug development : workshop summary

International regulatory harmonization amid globalization of drug development : workshop summary /

Show other versions (1)

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...

Full description

Saved in:
Bibliographic Details
Online Access: Full text (MCPHS users only)
Main Authors: Weisfeld, Victoria D. (Author), Lustig, Tracy A. (Author)
Corporate Author: International Regulatory Harmonization Amid Globalization of Biomedical Research and Medical Product Development (Workshop)
Format: Electronic Conference Proceeding eBook
Language:English
Published: Washington, D.C. : National Academies Press, 2013
Subjects:
Drug development.
Drugs > Testing > Standards.
Drug approval > Methods.
Drugs > Design.
Drug Design
Drug Evaluation > standards
Internationality
Legislation, Drug
Pharmaceutical Preparations > supply & distribution
Congress
proceedings (reports)
Conference papers and proceedings.
Local Note:ProQuest Ebook Central
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.

Similar Items