Safety monitoring and pharmacovigilance

Participants will gain an in-depth understanding of the regulatory requirements and best practices for ensuring the safety of participants throughout the clinical trial process. Through case studies and practical examples, participants will learn how to effectively monitor and assess adverse events, implement risk management strategies, and ensure compliance with pharmacovigilance regulations. The course will also cover the role of safety monitoring committees and the importance of effective communication in ensuring patient safety and regulatory compliance.

• Introduction to Safety Monitoring and Pharmacovigilance
• Regulatory Framework for Safety Monitoring in Clinical Trials
• Adverse Event Reporting Requirements and Timelines
• Pharmacovigilance Systems and Processes
• Signal Detection and Risk Management
• Safety Monitoring Committee (DSMC/DMEC) Operations
• Safety Data Management and Analysis
• Risk Communication and Management Plans