Scaling Pharmacovigilance: From Clinical Development to Commercialization

As biopharmaceutical organizations move from clinical development into commercialization, pharmacovigilance must evolve from a functional requirement into a strategic business capability. Global expansion, increasing regulatory expectations, growing data volumes, and new technology demands can quickly expose gaps in operating models that were sufficient during development but are not built for commercial-scale operations.

Drawing on more than 30 years in the pharmaceutical industry and over 16 years of pharmacovigilance leadership, Nina Lahanis shares practical perspectives on building resilient PV organizations that can support growth while maintaining compliance and oversight. Key considerations include governance structures, technology investments, organizational design, and approaches to scaling operations across global markets.

Attendees will gain valuable insights into assessing commercial readiness, making informed strategic decisions, and avoiding common challenges that can hinder long-term success. Explore proven leadership lessons and practical frameworks for creating a pharmacovigilance organization prepared for the realities of commercialization.