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Tuesday, November 3 • 10:20am - 11:05am
Ownership of the TMF as a Central Repository

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  • Challenges of a single repository
  • Challenges around ownership of the TMF
  • Areas of progress

Moderators
avatar for Barbara Hepworth-Jones

Barbara Hepworth-Jones

Director, Clinical Development Regulations and Advocacy, Quality & Risk Management, R&D Clinical Operations, GSK
Barbara Hepworth-Jones is Director of Quality and Risk Management at GSK. This includes ensuring GSK’s global processes, procedures and training meet current and future regulatory requirements and GCP, and supporting GCP inspection readiness. Barbara has a PhD from the University... Read More →

Speakers
avatar for Christa Lewiski

Christa Lewiski

Study File Manager (TMF Head), Seqirus
Christa Lewiski is TMF Head, Study File Manager at Seqirus for the last 2 years. She is responsible for Seqirus’s Veeva Vault TMF system and all TMF processes. She has over 18 years of experience in TMF/clinical document management within the biopharmaceutical industry.
avatar for Priya Chaturvedi, PhD.

Priya Chaturvedi, PhD.

VP, Clinical Quality Assurance, Eisai, Inc.
Priya Chaturvedi is currently the VP and Head of Global Clinical Quality Assurance at Eisai. Prior to joining, Eisai Inc., Priya served as Executive Director, Clinical Quality Assurance at Merck. Prior to Merck, Priya was at Pfizer in the Quality oversight roles in Clinical and Med... Read More →
avatar for Katrien Clinckx

Katrien Clinckx

Director, Head TMF Operations & Clinical Support, Galapagos
Clinical study experience since 2005, as CRA and study manager/lead in CRO & pharma companies. Since 2016, member of the Clinical Operations management team at Galapagos NV, a fast growing Biotech company. Lead the implementation of eTMF and TMF processes. Set-up and leading the TMF... Read More →


Tuesday November 3, 2020 10:20am - 11:05am EST