Integration of Pharmacovigilance in Drug Life Cycle
Integrating pharmacovigilance throughout the entire drug life cycle enhances patient safety and regulatory compliance. From preclinical development through post-market surveillance, safety data must be systematically collected, analyzed, and acted upon. Early incorporation of risk management strategies helps shape trial protocols and mitigate anticipated risks. During clinical development, adaptive monitoring and periodic safety reports ensure continuous safety oversight. Once approved, ongoing pharmacovigilance activities such as spontaneous reporting, signal detection, and risk minimization are vital to identify and manage real-world safety issues. Regulatory frameworks increasingly emphasize lifecycle risk management, requiring dynamic updates to safety profiles and risk mitigation plans. Cross-functional collaboration among clinical, regulatory, and safety teams is essential for seamless data integration. This session presents methodologies and tools for embedding pharmacovigilance at every stage of development, ultimately fostering a proactive safety culture that benefits both regulators and patients.
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Integration of Pharmacovigilance in Drug Life Cycle Conference Speakers
Recommended Sessions
- Advances in Risk Management Planning
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