Global Pharmacovigilance and Risk Management Strategies Conference

Pharmacovigilance is fundamental to safeguarding public health and relies on a comprehensive approach that includes effective risk management, accurate safety reporting, regulatory oversight, and collaboration across stakeholders. This session highlights recent advancements in these areas, beginning with a presentation on FDA updates including REMS integration with data standards, and a review of the FDA Guidance on the REMS Logic Model as a framework for linking program design with assessment. Attendees will gain insights on the FAERS public dashboard and the transition to the ICH E2B(R3) standard with a focus on the implications of these advancements for data quality, consistency, and FDA oversight. The final presentation will address the complexities of safety labeling updates while highlighting the responsibility of pharmaceutical companies, the oversight of regulatory agencies, and the challenges of achieving alignment across global stakeholders.