Global Certificate in Drug Safety Surveillance Essentials
-- ViewingNowThe Global Certificate in Drug Safety Surveillance Essentials is a comprehensive course that equips learners with critical skills in drug safety. This certification program emphasizes the importance of pharmacovigilance, a rapidly growing field with high industry demand.
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⢠Introduction to Drug Safety Surveillance: Basics of pharmacovigilance, adverse drug reactions, and the importance of drug safety surveillance
⢠Regulatory Framework for Drug Safety: International regulations and guidelines for drug safety surveillance, including FDA, EMA, and ICH
⢠Pharmacovigilance Risk Management: Risk identification, assessment, and minimization in drug safety surveillance
⢠Signal Detection and Management: Techniques for identifying and managing safety signals, including disproportionality analysis and data mining
⢠Pharmacoepidemiology and Observational Studies: Epidemiological methods and observational studies in drug safety surveillance
⢠Safety Analysis and Reporting: Analysis and reporting of safety data, including safety summaries and periodic safety update reports
⢠Clinical Trial Safety: Safety monitoring in clinical trials, including serious adverse event reporting and safety data monitoring committees
⢠Risk Communication: Communicating safety risks to healthcare professionals, patients, and the public
⢠Drug Safety Surveillance in Special Populations: Safety surveillance considerations in special populations, including children, pregnant women, and the elderly
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