International regulatory harmonization amid globalization of drug development : workshop 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...

Descripción completa

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autores principales: Weisfeld, Victoria D. (Autor), Lustig, Tracy A. (Autor)
Autor Corporativo: International Regulatory Harmonization Amid Globalization of Biomedical Research and Medical Product Development (Workshop)
Formato: Electrónico Congresos, conferencias eBook
Idioma:Inglés
Publicado: Washington, D.C. : National Academies Press, [2013]
Temas:
Drug development.
Drugs > Testing > Standards.
Drug approval > Methods.
Drugs > Design.
Drug Design
Drug Evaluation > standards
Internationality
Legislation, Drug
Pharmaceutical Preparations > supply & distribution
Médicaments > Développement.
Médicaments > Essais cliniques > Normes.
Médicaments > Conception.
MEDICAL > Pharmacology.
Drugs > Design
Drug approval
Drug development
Drugs > Testing > Standards
Congress
proceedings (reports)
Conference papers and proceedings
Methods (Music)
Conference papers and proceedings.
Actes de congrès.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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.

Ejemplares similares