Course Features
- Lectures 0
- Quizzes 0
- Duration 5 weeks
- Skill level Beginner
- Language English
- Students 295
- Assessments Yes
Curriculum
- 10 Sections
- 0 Lessons
- 5 Weeks
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- Introduction to PharmacovigilanceCovers the basics of pharmacovigilance (PV), its history, and its significance in healthcare. Introduces key terms, objectives, and the role of PV in ensuring medication safety.0
- Classification and Scales in PharmacovigilanceExamines the classification of adverse drug reactions and causality assessment scales, such as Naranjo and WHO-UMC, to assess causality, severity, and preventability of drug-related events.0
- MedDRA: Medical Dictionary for Regulatory ActivitiesProvides an overview of MedDRA terminology, structure, and applications in PV, including standardized coding of medical information, classification levels, and its importance in regulatory reporting.0
- Surveillance Techniques in PharmacovigilanceExplores active and passive surveillance techniques, spontaneous reporting, cohort event monitoring, and post-marketing surveillance to monitor drug safety in real-world settings.0
- Signal Detection and AssessmentCovers methods for detecting safety signals from PV data, including disproportionality analysis and data mining, and explains the signal evaluation process and decision-making criteria.0
- Regulatory PharmacovigilanceDiscusses global and regional PV regulations, including ICH, FDA, EMA, and CDSCO guidelines, covering reporting requirements, regulatory compliance, and the PV lifecycle from drug development to post-market.0
- Quality Assurance and ComplianceIntroduces quality assurance measures in PV, such as auditing, SOPs, and GVP (Good Pharmacovigilance Practices), emphasizing maintaining PV data quality, consistency, and compliance with regulatory standards.0
- Pharmacovigilance in the Pharmaceutical IndustryFocuses on how PV is integrated within pharmaceutical companies, covering in-house PV processes, industry roles, risk management plans, and challenges in ensuring drug safety from development through marketing.0
- Pharmacovigilance Databases: An OverviewIntroduces major PV databases, such as WHO VigiBase, etc focusing on their roles in adverse event reporting, data entry standards, and analysis tools.0
- Panel DiscussionDiscussion about case assessments, career opportunities, and anything you’re looking for direct guidance.0
