Track 1: Clinical Safety, Pharmacovigilance, and Risk Management
This track provides an overview of the evolving global regulatory environment in clinical safety, pharmacovigilance, and risk management for medical products, including biopharmaceuticals, advanced therapies, and medical devices. Sessions focus on proactively identifying, assessing, and mitigating risks to protect patient safety, while incorporating the patient voice into the pharmacovigilance ecosystem. Forward-thinking discussions explore the application of new technologies, real-world data sources, and advanced analytical techniques to enhance safety signal detection, strengthen benefit-risk assessment and communication, and optimize risk management planning and execution across the product lifecycle as regulatory requirements evolve and medical product development becomes increasingly global.
- 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 patient 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.
- Pharmacovigilance for Combination Products, Medical Devices, and Advanced Therapies: Unique monitoring considerations for diverse product types, including generics, biosimilars, and ATMP
- Special Populations in Pharmacovigilance: Tailored safety monitoring and risk mitigation strategies for pediatrics, pregnancy, rare diseases, and underrepresented populations
- Measuring the Impact of Risk Management and Mitigation Strategies: Evaluating effectiveness of risk minimization measures, labeling, and safety communications throughout the product lifecycle
- AI and Technology-Enabled Safety Analytics: Leveraging AI, machine learning, real-world datasets, and novel data sources for improved safety signal detection and proactive risk mitigation
- Pharmacogenomics and Personalized Safety Monitoring: Using genetic insights to predict, monitor, and manage adverse events, enhancing individualized patient safety
- 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 AI, machine learning, and emerging technologies enhance signal detection, aggregate safety assessments, and proactive risk mitigation?
- What strategies best measure the effectiveness of risk management plans to ensure true impact on patient safety across diverse populations and products?
-
Safety Risk Management: A Focus on EU RMPs and US REMS
Learn More! -
Safety and Pharmacovigilance Certificate Program Core Track Online Package
Learn More! -
Benefit-Risk Assessment and Management Across the Lifecycle
Learn More! -
Basic Safety Sciences: Pharmacoepid emiology, Clinical Pharmacology, Pharmacogenomics, and Toxicology Studies
Learn More! -
Workshop on Automation and Artificial Intelligence in Signal Management
Learn More! -
Medical Devices and Drug-Device Combination Products Workshop: Post-Market Surveillance and Clinical Evidence
Learn More!