Global Certificate Pharmaceutical Regulations: International Standards
-- ViewingNowThe Global Certificate Pharmaceutical Regulations: International Standards course is a crucial program for professionals seeking expertise in international pharmaceutical regulations. This course highlights the importance of regulatory compliance in the global pharmaceutical landscape, addressing both theoretical knowledge and practical applications.
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โข Introduction to Pharmaceutical Regulations: Overview of global regulations, international standards, and compliance requirements.
โข Good Manufacturing Practices (GMPs): Explanation of GMPs, their importance, and international variations, including WHO GMP and EU GMP.
โข Pharmaceutical Quality System (PQS): Understanding the PQS, ICH Q10, and its role in ensuring pharmaceutical quality and compliance.
โข Regulatory Affairs and Dossier Management: Introduction to regulatory affairs, dossier management, and global submissions.
โข Pharmacovigilance and Risk Management: Overview of pharmacovigilance, risk management, and global requirements for drug safety monitoring.
โข Clinical Trials Regulations: Explanation of international clinical trial regulations, ICH GCP, and ethical considerations.
โข Import and Export Controls: Overview of import/export regulations, customs procedures, and international trade agreements.
โข Labeling, Packaging, and Promotion: Understanding global labeling, packaging, and promotion requirements, including ICH E6.
โข Inspection and Enforcement: Introduction to inspection processes, enforcement actions, and best practices for handling regulatory authority inspections.
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