Global Certificate in Drug Safety Monitoring Fundamentals
-- ViewingNowThe Global Certificate in Drug Safety Monitoring Fundamentals is a comprehensive course designed to equip learners with critical skills in drug safety. This certificate program emphasizes the importance of pharmacovigilance, a rapidly growing field with high industry demand.
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โข Introduction to Drug Safety Monitoring: Understanding the importance of pharmacovigilance, its role in public health, and the global regulatory landscape. โข Adverse Event Reporting: Identifying, collecting, and reporting adverse events, including spontaneous reporting, intensive monitoring, and signal detection. โข Pharmacovigilance Systems: Designing, implementing, and maintaining pharmacovigilance systems, including data management, processing, and analysis. โข Risk Management Plans: Developing, implementing, and updating risk management plans to identify, assess, and mitigate risks associated with drug use. โข Regulatory Compliance: Understanding and complying with global drug safety regulations, guidelines, and standards, including ICH, FDA, and EMA requirements. โข Pharmacovigilance Audits: Conducting internal and external audits of pharmacovigilance systems, processes, and procedures to ensure compliance and continuous improvement. โข Signal Detection and Evaluation: Identifying, evaluating, and managing safety signals using statistical and epidemiological methods. โข Benefit-Risk Assessment: Balancing the benefits and risks of drug use, including risk-benefit analysis, risk communication, and decision-making. โข Pharmacovigilance in Special Populations: Addressing the unique safety concerns of special populations, such as children, pregnant women, elderly, and patients with rare diseases. โข Quality Management in Pharmacovigilance: Implementing quality management principles in pharmacovigilance, including quality assurance, quality control, and continuous improvement.
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