Connecting the Industry
To Advance Strategic TMF

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.

Rino Nascari Bristol Myers Squibb
Head, TMF and Transparency

Mano Das Bristol Myers Squibb
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.

Jonathan Bissell Astellas Pharma
Business Operations Lead, TMF Systems & Archive

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.

Dawn Buchanan AffyImmune Therapeutics, Inc.
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.

Julie Kmiec AbbVie
Associate Director, Operations

Rebecca Halbur Moderna
Associate Director, TMF Records Management