Benefit-Risk Assessment in Pharmacovigilance MasterClass

Topics

• Benefit-risk assessment
• Principles, basic definitions, and frameworks
• Benefit risk methodologies by regulators (i.e. FDA, EMA)
• Patient perspective and its incorporation

Who should Attend

• 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