Global Certificate in Drug Regulation & Compliance
-- ViewingNowThe Global Certificate in Drug Regulation & Compliance is a comprehensive course designed to meet the growing industry demand for professionals with expertise in drug regulation. This course provides learners with a solid understanding of the complex regulatory landscape, quality assurance, and compliance requirements for pharmaceuticals.
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โข Introduction to Drug Regulation: Overview of global regulatory bodies, regulations, and guidelines
โข Pharmaceutical Quality Systems: Quality assurance, quality control, and GMPs
โข Drug Development & Clinical Trials: Phases, design, conduct, and reporting
โข Pharmacovigilance & Safety Monitoring: Adverse event reporting, signal detection, and risk management
โข Regulatory Affairs: Regulatory strategy, submissions, and approvals
โข Labeling & Packaging Compliance: Content, format, and language requirements
โข Marketing Authorization & Lifecycle Management: Variations, renewals, and withdrawal
โข Global Regulatory Intelligence: Regulatory updates, trends, and harmonization
โข Inspection Readiness & Quality Management: Preparation, response, and continuous improvement
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