Cover image for Pharmaceutical Regulatory Environment Challenges and Opportunities in the Gulf Region
Title:
Pharmaceutical Regulatory Environment Challenges and Opportunities in the Gulf Region
Author:
Al-Essa, Reem K. author.
ISBN:
9783319175904
Edition:
1st ed. 2015.
Physical Description:
XIII, 236 p. 79 illus. in color. online resource.
Contents:
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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