Donatella Ballerini Montrium

With 16 years of experience in the pharma industry, I first gained expertise at Chiesi Farmaceutici in the Global Clinical Development Department, focusing on clinical studies in Rare Disease and Neonatology. Later, in the Global Rare Disease Department, I served as a Document & Training Manager, where I developed and implemented documentation management processes, leading the transition from paper to eTMF. In 2020, I became the Head of GCP Compliance and Clinical Trial Administration Unit at Chiesi, ensuring all ClinOps processes complied with ICH-GCP standards and maintained inspection readiness. In 2021, my big passion for Trial Master File, took me to join Montrium as the Head of eTMF Services, with the opportunity to support companies in their TMF journey . I help pharmaceutical companies in QMS implementation and process improvement as an independent GCP Consultant as well. Additionally, I have been a member of the CDISC TMF Reference Model Education Governance Committee since 2023 and the CDISC Risk White Paper Initiative since 2024.

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