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Wednesday, November 15 • 16:30 - 17:15
Panel: Setting a Foundation for Success to Meet ICH E6(R3) TMF Expectations

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  • Review the changes in the draft guidelines and their impact on clinical records management
  • Examine the risk-based approach deployed by Sponsors and Investigator Sites

avatar for Barbara Hepworth-Jones

Barbara Hepworth-Jones

Director of Capability, GSK
Barbara is Director of Capability at GSK, with responsibility for capability, learning and development for GSK’s Clinical Operations division. This includes supporting capability development for clinical development, monitoring, data management and clinical laboratory staff.Barbara... Read More →
avatar for Martin Hausten

Martin Hausten

Senior Principal Capability Manager, Boehringer Ingelheim
In his role as Head of Global Document Quality Centre Martin is responsible for the harmonization and standardization of global trial master file end- to end process.Leading a team of internationally working, highly skilled Document/Record Specialists – ensuring service management... Read More →
avatar for Octavian Mihaita

Octavian Mihaita

Senior Specialist, Global TMF Management, Beigene
Currently a Senior TMF Specialist with BeiGene's Global TMF Management department, I built my area of expertise fulfilling various TMF roles with mid-size and large CRO and Pharma companies over the past 11 years, with various levels of responsibility, driving and overseeing end-to-end... Read More →
avatar for Vincent Yeung

Vincent Yeung

Director R&D Quality and Risk Management, Vertex Pharmaceuticals
As R&D Director of Quality Vincent is responsible for inspection readiness, regulatory intelligence, and process improvement. He is the chair of Vertex’s Clinical Trial Regulation Transition Steer Committee. Prior to the current role he was an Amgen auditor for seven years in GCP... Read More →

Wednesday November 15, 2023 16:30 - 17:15 GMT