Track 1: Clinical Safety, Pharmacovigilance, and Risk Management
This track focuses on how organizations navigate the evolving global landscape of clinical safety, pharmacovigilance, and risk management for medical products, including biopharmaceuticals, advanced therapies, and medical devices. Sessions examine proactive approaches to identifying, assessing, communicating, and mitigating safety risks while incorporating the patient voice throughout the pharmacovigilance ecosystem. Forward-thinking discussions highlight the application of emerging technologies, real-world data sources, and advanced analytical techniques to strengthen safety signal detection, enhance benefit-risk assessment and communication, and optimize risk management strategies across the product lifecycle as regulatory expectations evolve, and medical product development becomes increasingly global.
Themes
- Global Pharmacovigilance Regulations and Cross-Industry Collaborations: Updates on evolving regulatory requirements, harmonization efforts, and collaborative approaches worldwide
- Patient Engagement and Preference Studies in Safety and Risk Management: Practical approaches to embedding patient perspectives and formal preference methodologies into safety monitoring, benefit-risk decisions, and access planning. This includes the use of scientifically validated patient preference studies conducted in parallel with clinical trials to strengthen product dossiers and support regulatory and reimbursement decisions
- Measuring the Impact of Risk Management and Mitigation Strategies: Evaluating the effectiveness of risk minimization measures, labeling, and safety communications throughout the product lifecycle
- AI and Technology-Enabled Safety Surveillance and Analytics: Use cases on leveraging AI for improved pharmacovigilance operations including case management, safety signal detection, noise reduction, assessments, and proactive risk mitigation. Practical controls for compliance, oversight, and inspection readiness.
- Pharmacovigilance for Combination Products, Medical Devices, and Advanced Therapies: Unique monitoring considerations for diverse product types, including generics, biosimilars, and ATMPs
- Special Populations in Pharmacovigilance: Tailored safety monitoring and risk mitigation strategies for pediatrics, pregnancy, rare diseases, and underrepresented populations
- Pharmacogenomics and Personalized Safety Monitoring: Using genetic insights to predict, monitor, and manage adverse events, enhancing individualized patient safety
Key Questions to be Addressed
- How can global pharmacovigilance frameworks and collaborations improve consistency, speed, and quality in safety monitoring and reporting, and improve the utilization of reportable information by health authorities?
- How can structured patient preference studies enhance benefit-risk decision-making, access planning, and communication with regulatory authorities?
- How can emerging technologies improve signal management and proactive risk mitigation?
- What strategies best measure the real-world effectiveness of risk management plans and mitigation measures to ensure true impact on patient safety across diverse populations and products?
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Safety Risk Management: A Focus on EU RMPs and US REMS
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Safety and Pharmacovigilance Certificate Program Core Track Online Package
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Benefit-Risk Assessment and Management Across the Lifecycle
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Basic Safety Sciences: Pharmacoepid emiology, Clinical Pharmacology, Pharmacogenomics, and Toxicology Studies
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Workshop on Automation and Artificial Intelligence in Signal Management
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Medical Devices and Drug-Device Combination Products Workshop: Post-Market Surveillance and Clinical Evidence
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