Sara Montanari | Head of PV, Regulatory Affairs & Medical Affairs QA
Menarini Stemline
- Dr. Sara Montanari is a seasoned GxP Quality Assurance leader with a robust background in biomolecular sciences and genetics, bringing nearly two decades of extensive life sciences and QA expertise spanning top-tier CRO and pharmaceutical environments.
- Since joining Menarini in 2020, she founded and scaled the R&D Quality Assurance department from the ground up, initiating digital transformation across all GxP areas while blending clinical research, epidemiology, and Real-World Evidence (RWE).
- As the current Head of the PV, Regulatory, and Medical Affairs QA Team, she supported the establishment of the pharmacovigilance framework for Menarini's oncology portfolio, successfully leading major FDA/EMA inspections and global GCP readiness programs to support marketing authorizations and geographic expansion.
- Driven by an innate curiosity, Dr. Montanari is highly focused on deploying innovative, data-driven strategies—including the integration of AI—to advance compliance frameworks, strengthen modern safety oversight, and support agile regulatory decision-making.
Appearances:
Day 0: 22nd September @ 14:00
Workshop - Clinical Safety and AI
Day 2: 24th September @ 15:00
Quality Assurance Panel 6 – The changing landscape of PV inspections
last published: 23/Jun/26 20:55 GMT
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