Global TMF Summit

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 →

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.

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 →

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 →