Signal Detection and Regulatory Expectations focuses on signal detection, safety reviews, and regulatory expectations, equipping professionals with the knowledge to manage signals and risks effectively in compliance with evolving regulations.
Topics
- Signal Detection and Signal Management
- Safety Review Cycle
- Risk-Benefit Analysis
- Benefit-Risk Determinations
- Quantitative Signal Assessments
- Safety Communication (CCSI/SCSI and Labelling)
- Regulatory Requirements for Signal Detection (EU/FDA)
- EudraVigilance Quantitative Signal Tool
- Urgent Safety Restrictions
- Links to RMP/REMs
- Practical Examples and Scenarios
Who should Attend
- Regulatory Personnel
- Drug Safety/Pharmacovigilance Professionals
- Staff Responsible for Product Labelling Amendments
- Professionals Involved in CCSI/DCSI Production
- Professionals Working on Risk Management Plans (RMPs/REMs)
