Connecting Leaders to
Advance Strategic TMF
Agenda
Wednesday, April 17
Thursday, April 18
BMS: Improving TMF Efficiency and Quality with Automation
BMS shares their TMF automation strategy, including lessons learned, common pitfalls, and successful efforts to improve TMF quality. They’ll examine how robotic process automation (RPA) and other bots can reduce manual input while improving compliance.
Head, TMF and Transparency
Director, IT, Trial Operations
Astellas: Refining a Risk-Based TMF Management Approach
Astellas shares lessons learned from two years of refining a customized risk-based TMF management approach. They also detail new efforts to create a study health score to quickly identify where TMF remediation is required.
Business Operations Lead, TMF Systems & Archive
Discussion: Risk-Based TMF for Large and Small Biopharmas
Discuss best practices for risk-based TMF management with peer companies. This includes identifying criteria to assess risk and determining how to define and approach primary and secondary QC.
AffyImmune: Incorporating Quality by Design into TMF Management
AffyImmune Therapeutics details how smaller biopharmas can practically incorporate quality by design (QbD) principles into strategic TMF plans. They also share how larger biopharmas can assess M&A candidates' TMF quality to determine next steps.
Vice President, Clinical Operations
Discussion: Best Practices for Completeness Planning and Tracking in Vault eTMF
Discuss best practices for completeness planning and tracking in Vault eTMF in this interactive session. Get recommendations from Veeva product leaders to leverage new capabilities like the milestone workspace, and share learnings with peer companies.
Discussion: Assessing New Inspection Trends
Assess new inspection trends from a variety of regulatory agencies, get tips to better prepare for your next inspection, and share audit and inspection learnings with peer companies.
Biopharma Panel: Assessing TMF Operating Models for Quality and Efficiency
AbbVie and Moderna discuss the pros and cons of different TMF operating models, including centralized and decentralized models for document processing. They also share best practices for driving TMF completeness.
Associate Director, Operations
Associate Director, TMF Records Management