Donatella Ballerini

With 20 years of experience in the pharma industry, Donatella Ballerini first gained expertise at Chiesi Farmaceutici in the Global Clinical Development department, focusing on clinical studies in Rare Disease and Neonatology. Later, in Global Rare Disease, Donatella served as a Document and Training Manager, where she developed and implemented documentation management processes, leading the transition from paper to eTMF. In 2020, she became the Head of the GCP Compliance and Clinical Trial Administration Unit at Chiesi, ensuring all clinical operations processes complied with ICH-GCP standards and maintained inspection readiness. In 2021, she joined Montrium as the Head of eTMF Services, where she helps pharmaceutical companies in eTMF implementation and process improvement, and works as an independent GCP consultant.