Signal Management In Pharmacovigilance

Signal Management In Pharmacovigilance is the process of identifying, assessing, prioritizing, and communicating potential safety concerns (or "signals") related to pharmaceutical products. The course provides a comprehensive understanding of signal detection, validation, and communication within regulatory frameworks.

Key Topics

• Qualitative and Quantitative Methodologies for Signal Detection
• Implementation, Oversight, and Governance of Signal Management Processes
• Regulations and Guidance on Signal Management
• Role of Social Media in Signal Detection
• Signal Validation and Prioritisation
• Introduction to EVDAS and Its Expected Use
• Potential Inspection Findings and How to Avoid Them
• Signals of Disproportionate Reporting
• Signal Communication
• Linking Signal Management with PSUR and Risk Management Plans
• Group Discussions on Signal Validity and Assessment Steps

Who should Attend

• Regulatory Affairs Specialists
• Drug Safety Officers
• Pharmacovigilance Professionals
• Compliance Managers
• Quality Assurance Professionals
• Risk Management Professionals
• Pharmaceutical Consultants