Professional Certificate in Drug Safety & Benefit-Risk Management
-- ViewingNowThe Professional Certificate in Drug Safety & Benefit-Risk Management is a comprehensive course designed to equip learners with critical skills in drug safety evaluation and benefit-risk management. This course is crucial in the pharmaceutical industry, where the demand for professionals who can effectively assess drug safety and communicate risks to stakeholders is high.
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โข Introduction to Drug Safety & Benefit-Risk Management: Overview of drug safety, pharmacovigilance, and benefit-risk management concepts
โข Pharmacology & Pharmacodynamics: Basic principles and concepts of pharmacology, including drug action, distribution, metabolism, and excretion
โข Clinical Trials & Data Analysis: Phases of clinical trials, data collection, analysis, and interpretation for benefit-risk assessments
โข Adverse Event Reporting & Monitoring: Spontaneous reporting, causality assessment, and safety signal detection
โข Risk Management Plans: Designing, implementing, and monitoring risk minimization strategies
โข Regulatory Affairs in Drug Safety: Overview of regulatory frameworks, guidelines, and requirements for drug safety and benefit-risk management
โข Benefit-Risk Assessment Methodologies: Quantitative and qualitative methods for assessing and communicating benefit-risk balance
โข Pharmacoepidemiology & Real-World Evidence: Study designs, data sources, and analytical methods for post-authorization safety studies
โข Patient-Centered Drug Safety: Incorporating patient perspectives, experiences, and values in benefit-risk assessments
โข Ethics & Professionalism in Drug Safety: Ethical considerations, decision-making, and professional responsibilities in drug safety and benefit-risk management
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