During its recent meeting held from 29 September to 2 October 2025, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) addressed critical safety assessments and risk management strategies concerning medicinal products. This session underscored the committee’s ongoing commitment to evaluating safety signals and their implications for public health, reflecting the evolving landscape of pharmacovigilance.
The discussions included an in-depth analysis of emerging safety signals and their potential impact on existing drug approvals. With an increasing focus on real-world data, PRAC’s findings are pivotal for regulatory professionals and quality assurance teams as they navigate compliance and risk mitigation in their operations. The outcomes from this meeting will likely inform future regulatory decisions and influence the development of safety monitoring frameworks across the pharmaceutical industry.
As the pharmaceutical landscape continues to evolve, the insights generated by PRAC serve as a crucial resource for stakeholders involved in drug safety and risk management. The implications of these discussions extend beyond compliance, shaping the strategic approaches of companies in sourcing, CMC, and portfolio management.
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