TMF inspection readiness is not a one-time event, it’s a mindset. It’s how you perform and approach your TMF responsibilities every day that guarantees the quality of your clinical trial. In our upcoming webinar, we'll provide you with the tools you need to achieve this mindset, including TMF management best practices and approaches to ensure inspection readiness success. 

Who is this webinar for?

The webinar will provide actionable insights for professionals working in:

• Representatives from Sponsors & CROs
• Trial Document and Records Management 
• Clinical Operations 
• Quality Assurance/Clinical Compliance 
• Regulatory Affairs/Operations 
• Study/Project Management

What you will learn:

• Planning and execution for inspection readiness 
• Why an eTMF is your secret weapon for inspection success 
• Measuring if your TMF is inspection ready 
• Developing a risk-based approach for your TMF 
• People, processes, and technology to maintain a real-time inspection-ready TMF 
   

Speaker

 
Donatella Ballerini, Head of  eTMF Services at Montrium

Donatella began her career in the pharmaceutical industry 12 years ago in Global Clinical Development at Chiesi Farmaceutici where she managed Late Phase Clinical Trials on Neonatology and Rare Disease, focusing on clinical documentation management. As Document & Training Manager, Donatella implemented documentation management processes in the department and served as the leading ambassador to move from paper to an electronic Trial Master File. A focused expertise in GCP and Inspection Readiness supports her in developing process improvement initiatives, system implementation and oversight. In 2020 she became Head of the GCP Compliance and Clinical Trial Administration Unit in Chiesi Farmaceutici. The scope of the Unit was to ensure the compliance of all the Clinical Operation Processes with ICH-GCP as well as to guarantee a continuous Inspection Readiness of the TMF. Her expertise and passion for TMF have now led her to become Head of eTMF Services at Montrium. She is passionate about supporting companies in developing eTMF processes and strategies to succeed.