By attending this course, you will learn

• Definition of active substance, excipient, medicinal product, adverse event, adverse reaction, causality, primary source, medical confirmation, suspect, concomitant and interacting drug
• Definition of ICSR and minimum validity criteria for ICSR
• Definition of serious adverse reaction, seriousness criteria and difference between seriousness and severity
• Definition of SUSAR and its submission timelines
• Basics about reporting of AEs
• Key stages for ICSR management and quality management requirements
• Purpose and structure of EudraVigilance
• ICSR submission timelines
• Different types of safety reports and how they are classified
• Use of the product outside the terms of the marketing authorization
• Management of occupational exposure, exposure during pregnancy and breastfeeding reports
• Management of lack of efficacy reports
• Management of suspected transmission via a medicinal product of an infectious agent and suspected adverse reactions related to quality defect or falsified medicinal product
• Screening and management of literature reports
• When Marketing Authorisation Holder should consider the product as its own?
• Responsibilities of Competent Authorities and Marketing Authorization Holders
• Management of significant/non-significant follow-up reports
• Management of report amendment and nullification

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