The FDA Group's CEO, Nick Capman, sits down with Donna Dorozinsky, founder and CEO of Just in Time GCP, to discuss key considerations for Trial Master File (TMF) management and GCP compliance.
Discussion points include:
» The TMF's significance in capturing a study's complete story, including its challenges and achievements and its pivotal role in GCP compliance.
» The evolution of TMF structuring, the development of the TMF Reference Model for standardization, and its benefits for simplifying content integration across different organizations and vendors.
» Donna’s three components of a quality TMF: record quality, timeliness of filing, and completeness, explaining how these factors contribute to maintaining a compliant and effective TMF.
» Considerations for companies that outsource TMF management to CROs.
» The adoption of eTMF systems, especially for smaller companies, and the balance between investment in technology and maintaining compliant TMF practices.
» The challenges and considerations of TMF management during mergers and acquisitions (highlighting the importance of a complete and accessible TMF in these transitions).
» How the TMF is utilized during regulatory inspections, the recent focus of regulatory authorities on TMF compliance, and the importance of a well-managed TMF in demonstrating the quality and integrity of a study.
Donna is a Registered Nurse and business consultant who has spent over 30 years in drug development with extensive experience in study operations, including clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management.
Donna is a TMF Reference Model Steering Committee member and is a member of the Association of Women Entrepreneurs. She’s a founding member of the Society of Nurse Scientists, Innovators, Entrepreneurs, & Leaders. She serves on the Board of Trustees at Gwynedd Mercy University, where she received her BSN, and also has an MSN from Widener University.
Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. www.thefdagrou...
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