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Wednesday, September 29 • 9:30am - 10:00am
TRACK B: RBQM and TMF

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Explore the Application of Risk-Based Quality Management to the Trial Master File (TMF)
  • Review of the core principles of RBQM
  • Discuss a risk-based approach to TMFs
  • Showcase real examples of risk-based approaches and interpretation of results
  • Share recommendations for the future 

Speakers
avatar for Lisa D. Mulcahy

Lisa D. Mulcahy

TMF Management, AUTOLUS THERAPEUTICS
Lisa Mulcahy has an extensive career in the pharmaceutical industry in the areas of Clinical Operations, Quality Management, and Clinical Documentation Management. For the past 14 years, she has focused on developing and operationalizing high-quality and compliant management processes... Read More →
avatar for Darshan Patel

Darshan Patel

Customer Success Leader, IQVIA TECHNOLOGIES
Darshan Patel is a Customer Success leader for IQVIA eTMF systems. He is responsible for client relationships, training needs, system upgrades and migrations. Darshan has significant clinical experience in both CRO and sponsor settings, in several GXP environments. He has focused... Read More →


Wednesday September 29, 2021 9:30am - 10:00am EDT