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.
Key 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)
