Pharmacovigilance & Post-Marketing Safety

Long-term safety monitoring is essential for the success of biologics and biosimilars after market entry. This session will explore advanced pharmacovigilance strategies, risk management plans, and post-marketing surveillance systems that ensure ongoing safety and effectiveness. Topics include adverse event reporting, safety signal detection, real-world data integration, and the use of AI in safety monitoring. Attendees will learn how to design and implement robust risk mitigation frameworks that comply with global regulatory requirements. Comparative safety evaluations between originator biologics and biosimilars, including immunogenicity monitoring, will be highlighted. Emphasis will be placed on patient-centric pharmacovigilance models and how stakeholder education improves post-marketing outcomes. This session is tailored for safety officers, regulatory professionals, clinicians, and biopharma teams who are responsible for ensuring the safe and effective use of biologic therapies throughout their lifecycle.

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