Pharmaceutical Regulatory Environment Challenges and Opportunities in the Gulf Region /

The Middle East represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is con...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autores principales: Al-Essa, Reem K. (Autor), Al-Rubaie, Mohammed (Autor), Walker, Stuart (Autor), Salek, Sam (Autor)
Autor Corporativo: SpringerLink (Online service)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Cham : Springer International Publishing : Imprint: Adis, 2015.
Edición:1st ed. 2015.
Temas:
Public health.
Therapeutics.
Public Health.
Acceso en línea:Texto Completo
Tabla de Contenidos:
  • 1. Overview of Medicines Regulatory Systems in the Gulf Region
  • 2. The Regulatory Review Process in the Gulf Region
  • 3. Regulatory Review Times in the Gulf Region
  • 4. Quality Measures in the Gulf Regulatory Practices
  • 5. The Current Status of the Common Technical Document
  • 6. The Current Status of Drug Safety and Pharmacovigilance
  • 7. The Centralized Regulatory Review in the Gulf Region
  • 8. The Gulf States Assessment and Experience With the Centralised Procedure
  • 9. The Pharmaceutical Companies Assessment and Experience With the Centralised Procedure
  • 10. Proposal For an Improved Centralized Regulatory System
  • 11. The Strategic Planning Process of the GCC Regulatory Authorities: Barriers And Solutions
  • 12. The Regulatory Dilemma in the Gulf Region: The Way Forward.

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