PHARMACOVIGILANCE ONLINE TRAINING IN INDIA

Pharmacovigilance online training Pharmacovigilance Basic: Legal basis for safety coverage as well as a historical perspective Basic definitions and tools Pre- and Post-marketing: Basic variations Pre-Marketed AEs Post-Marketed AEs The Importance of Adverse Event coverage Suspected sudden Serious Adverse Reaction Sources of ADRs Causality Lack of effectiveness Expectedness Minimum Criteria for coverage Expedited coverage An introduction to the Eudravigilance system Qualified Person for Pharmacovigilance (QPPV) needs Development Safety Update Reports European communication laws New EU Pharmacovigilance Legislation Pharmacovigilance Advanced: Types of Audits & Inspections Approaches Preparing for a Pharmacovigilance scrutiny Overview of the Pharmacovigilance Audit Best Practices Detailed Audit things Need for detection The Cost of Failure Signalling summary Regulatory needs Signal Detection Objectives Incidence, Numerator, divisor Need for the ready Mind Signal Detection Hierarchy Approach to detection Signalling Examples Risk assessment and management For more details: Hno , road no: 3 New Dilshuknagar nagar colony Dilshuknagar,Hyderabad – ,India Mobi No:+, Land line No: 040