Pharmacovigilance in Personalized and Precision Medicine
The rise of personalized and precision medicine has transformed traditional drug development and safety monitoring paradigms. These tailored therapies, often based on genetic, biomarker, or molecular profiling, introduce new challenges for pharmacovigilance. The small, genetically defined patient populations involved may lead to limited pre-market safety data, necessitating enhanced post-marketing surveillance. Additionally, the individualized nature of treatment response requires adaptive signal detection tools and robust risk-benefit analyses tailored to subgroups. Digital tools such as electronic health records (EHRs), wearable devices, and genomic databases play an increasingly vital role in monitoring therapy-specific adverse events. Regulatory bodies are adapting frameworks to evaluate safety signals in the context of individualized treatment. This session explores how pharmacovigilance systems are evolving to meet the safety needs of precision therapies and how real-world evidence can support ongoing evaluation in diverse patient populations.
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Pharmacovigilance in Personalized and Precision Medicine Conference Speakers
Recommended Sessions
- Advances in Risk Management Planning
- AI and Automation in Signal Detection
- Audits, Inspections, and PV Compliance Best Practices
- Benefit-Risk Assessment in Drug Development
- Data Integrity and Electronic Trial Master Files
- Digital Therapeutics and Safety Monitoring
- Emerging Challenges in Global Pharmacovigilance
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- Integration of Pharmacovigilance in Drug Life Cycle
- Patient-Centric Approaches in Clinical Trials
- Pharmacovigilance in Personalized and Precision Medicine
- Pharmacovigilance in Rare and Orphan Drugs
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- Post-Marketing Surveillance and Real-World Data
- Real-Time Safety Data Monitoring Strategies
- Risk-Based Monitoring and Trial Optimization
- Safety Reporting in Early Phase Trials
- Signal Prioritization and Management Techniques
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