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.
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
