The Benefit-Risk Assessment in Pharmacovigilance MasterClass covers topics such as:
- Benefit-risk assessment
- Principles, basic definitions, and frameworks
- Benefit risk methodologies by regulators (i.e. FDA, EMA)
- Patient perspective and its incorporation
The Benefit-Risk Assessment in Pharmacovigilance MasterClass intended for:
- Safety evaluation
- Drug safety and pharmacovigilance
- Risk management planning and development of formal Risk Management Plans/REMS
- Periodic safety reporting
- Regulatory strategy and regulatory affairs
- Medical writers
- Medical Affairs
- Clinical research
