Биотехнологии сталкиваются с новыми вызовами в фармаконадзоре и клинических испытаниях

Pharmacovigilance becomes more complex as biopharma companies move toward commercialization and global growth. In this webinar, Nina Lahanis draws on 30+ years of pharmaceutical experience and 16+ years in PV leadership to share practical lessons on building scalable operating models, preparing for commercial readiness, navigating technology and governance decisions, and strengthening resilience in an evolving regulatory environment. Register for actionable insights. Click here to learn more. As FDA timelines and AI-enabled development accelerate, biopharma’s biggest bottleneck may be its own ability to make earlier, cross-functional decisions. HRPPs and IRBs play different but connected roles in protecting research participants. Hear expert guidance, firsthand experiences, and questions that can help people make more informed decisions. Racing to bring a therapy to patients? Explore FDA's six expedited pathways—Fast Track, Breakthrough Therapy, QIDP, RMAT, Priority Review & Accelerated Approval—and find your best fit. The FDA’s real-time review pilot signals a massive shift in clinical operations, where continuously regulator-ready data becomes the foundation of future trial execution. Gene therapy requires early, rigorous safety planning and command of pediatric and biosafety rules. Early committee engagement reduces delays and strengthens high‑stakes trials. Prepare for ICH E6(R3) with integrated oversight, audit-ready data, and streamlined trial operations designed to reduce burden, accelerate timelines, and support compliance. Guest Column | By Cindy Henderson, Henderson Consulting LLC The CRO's value is not execution alone. It is the depth of perspective that comes from having seen hundreds of trials across disease areas and regulatory environments. Many clinical organizations believe they must clean data and unify systems before adopting agentic AI. New approaches show teams can start now, create value faster, and improve readiness as they scale. Multi-vendor trial models often limit visibility and coordination. Discover how centralized operations can streamline workflows, control costs, and improve stakeholder experiences.