Masterclass Certificate in Pharmacovigilance Essentials Basics Protocols
-- ViewingNowThe Masterclass Certificate in Pharmacovigilance Essentials Basics Protocols is a comprehensive course that provides learners with fundamental knowledge and skills in pharmacovigilance. This field is critical in ensuring drug safety and efficacy, making it essential in the pharmaceutical industry.
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โข Introduction to Pharmacovigilance: Definition, history, and importance
โข Drug Safety Basics: Adverse drug reactions, pharmacoepidemiology
โข Pharmacovigilance Systems: Spontaneous reporting, active surveillance
โข Regulatory Framework: FDA, EMA, ICH guidelines
โข Signal Detection and Management: Data mining, disproportionality analysis
โข Risk Management Plans: Benefit-risk assessment, safety specification
โข Pharmacovigilance in Clinical Trials: Protocols, safety monitoring
โข Pharmacovigilance Audits and Inspections: Quality assurance, GVP
โข Pharmacovigilance Outsourcing: Service providers, contracts
โข Emerging Trends: Real-world data, social media monitoring
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