Conference Designed for

• Benefit-risk Assessment and Communication
• Clinical Research
• Data Safety Monitoring and Analysis
• Drug Safety
• Health Outcomes
• Medical Affairs
• Medical Communications
• Medical Information
• Medical Writing
• Medical Product Safety Assessment
• Patient Engagement and Advocacy Groups
• Pharmacoepidemiology
• Pharmacovigilance
• Post-Market Studies
• Quality Assurance
• Quality Control
• Real-World Evidence Generation
• Regulatory Affairs
• Risk Management
• Safety Statistics

At the completion of this conference, the participant should be able to:

• Analyze global regulatory changes and harmonization efforts across FDA, EMA, MHRA, and other authorities
• Examine AI tools to enhance signal detection, automate literature reviews, and improve safety data analysis within regulatory frameworks
• Recognize patient perspectives to improve decision-making and safety outcomes
• Identify advanced methodologies for RMPs and REMS to optimize patient safety and compliance
• Evaluate real-world evidence (RWE) from claims and electronic health records for regulatory submissions and safety monitoring
• Discuss advanced signal detection methods, such as knowledge graphs and FDA Medical Queries (FMQs), to evaluate safety signals effectively
• Interpret statistical data to assess safety profiles, prioritize risks, and communicate findings accurately
• Recognize how to address safety challenges in special populations, including pediatrics, geriatrics, and rare diseases, through targeted risk assessments
• Describe strategies for efficient pharmacovigilance operations in resource-constrained settings, including adverse event management and outsourcing