Chiesi Pharmaceuticals

Donatella Ballerini

Document and Training Manager, Global Rare Disease R&D
Chiesi Pharmaceuticals

I started my career in Chiesi almost 11 years ago after some work experiences in different fields and a Master Degree in Touristic Science in Milan.

I was involved in the very first line with the big project of a New R&D Center in Parma for Chiesi and I started to work in the Engineering and Validation Department.

After some years, I moved to the Global Clinical Development where I managed Late Phase Clinical Trial on Neonatology and Rare Disease, focusing on TMF Management.

In 2019 a new division in Chiesi was born, the Global Rare Disease, and I became part of it as Document & Training Manager. After one year of very hard - but fantastic - work, the GRD R&D GCP Compliance and Clinical Trial Administration Unit was created and I became its Head. My daily work is to ensure the compliance of all the Clinical Operation Processes with ICH-GCP and in particular I’m chief of the project for moving from a paper TMF to an electronic one for GRD R&D. A very big adventure and challenge!

Donatella Ballerini’s Session(s)

10:15 am EST
Risk-Based Approach for Document Management

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