Co-Chair Lucy Hampshire – Director, Medicines Quality Organisation — Europe
Lucy has worked in the pharmaceutical industry since 2001 and is a Quality Director in the Medicines Quality Organisation division of Eli Lilly and Company Limited. Lucy leads a team providing country level quality oversight for activities relating to medical, regulatory and safety across Europe. Lucy started her career in industry in pharmacovigilance before moving into a quality oversight role. Lucy provides leadership and expertise in medical and pharmacovigilance quality systems, ensuring the update of processes impacted by EU GvP and GCP. Lucy has a vast experience in GvP inspections and since the beginning of 2015 took on quality oversight responsibilities for clinical activities, hosting a recent MHRA Sponsor and Site GCP inspection as well as providing leadership for other European GCP inspections.
Lucy has a BSc in Biological Sciences (Microbiology) and obtained an MSc Clinical Microbiology from Barts and The London School of Medicine and Dentistry. Lucy previously trained as a clinical scientist researching antimicrobial resistance before moving into the pharmaceutical industry.
Karen graduated as a pharmacist in South Africa and entered the life science industry working for Eli Lilly. In 1992, she moved into clinical research in the UK with Chiltern International, initially managing the Clinical Development Department across Europe. Latterly she started and globally managed a novel group, EDC Solutions. In 2007, Karen joined Phlexglobal as Chief Business Development Officer and in 2015 she moved into the role of Vice President, Client Solutions. With her clinical and EDC background, Karen has also taken on a lead role in Phlexglobal’s electronic Trial Master File initiative, to promote, develop and implement support of Client eTMF systems as well as Phlexglobal’s eTMF Solution – PhlexEview. Karen’s most recent role is that of Chief Strategy Officer where she is focussing on the strategic priorities for the company. Karen focuses on four key areas, being Key Clients, CROs, TMF Expertise and PhlexEview eTMF, in order to support the continued strong growth of Phlexglobal. Karen also co-chairs the TMF Reference Model, an industry-driven initiative to standardize the content, naming and structure of Trial Master Files.
Associate Director, Global Clinical Operations
Jane Twitchen – Associate Director, Global Clinical Operations
Jane is currently Associate Director, Systems and Operations for Biogen Idec’s Knowledge, Records and Information Strategies team. In this role, Jane is responsible for the implementation, enhancements and oversight of Biogen’s eTMF repositories and manages associated, peripheral operations. Jane is currently focussed on the successful integration of Biogen’s eTMF with their Strategic Partner’s system.
Jane holds a BSc in medical physics and a postgraduate certificate in management. Her 17+ year career has involved the delivery of complex global technology solutions, and has included stops at Covance, SAS and several software companies that provided services to the pharmaceutical industry. Prior to joining Biogen Idec, Jane worked for six years at Phlexglobal, initially leading the Project Management team implementing eTMF solutions and overseeing the delivery of a range of TMF QC, Remediation and Migration Projects. Her most recent role at Phlexglobal was Head of Quality, where she focused on optimizing Phlexglobal’s eTMF quality processes and workflows. Jane also remains an active member of the TMF Reference Model Quality and Metrics subcommittee.
Principal Competency Development Specialist
Anne-Mette Varney – Principal Competency Development Specialist
Anne-Mette Varney is working as a Competency Development Manager and TMF Process Manager within Trial Execution, Clinical Operations at Novo Nordisk A/S, where she is responsible for building the TMF maintenance organisation in a global environment and for driving the TMF strategy and cross-functional collaboration. During the past two years she has been LoB PM in the TMF Improvement Project optimising the TMF process and Inspection Readiness. Currently she is supporting a TMF IT Project as a TMF process expert.
Anne-Mette holds a bachelor’s in nursing and worked as a nurse for several years before moving to the pharmaceutical industry in 2000. During the past 14 years she has been working within safety and pharmacovigilance, project and program management in CROs, and in clinical operations as Senior International Trial Manager and TMF Process Manager.
Martina Duevel – Systems Excellence Project Leader
Martina Duevel joined the pharmaceutical industry seventeen years ago working first in the Clinical Quality Assurance department at Schering AG in Berlin and then in clinical project management at Bayer. In January 2015, she was assigned as Clinical Project Leader for eTMF implementation and maturation. Martina is now Systems Excellence Project Leader. She has a bachelor's degree in biochemistry and a PhD in the natural sciences
Wendy Koç is Senior Manager at Gilead Sciences International, based in the UK. She has 23 years of experience in pharma GCP compliance. During this time she has covered every aspect of clinical trials, worked in both Pharma, CRO and as a consultant.
Vittoria Sparacio – Head, Clinical Documentation Operations, GSK R&D Processes, Clinical Compliance Platforms and Sciences
Vittoria Sparacio leads the Clinical Documentation Operations group at GlaxoSmithKline Pharmaceuticals R&D, where she is accountable for the tactical implementation of a sustainable TMF delivery strategy. Vittoria previously established the Novartis Vaccines electronic Trial Master Files system as well as processes and standards in document management and archiving for quality and compliant clinical studies. She also led inspection readiness programs, clinical operational excellence initiatives and contributed to the DIA TMF Reference Model working group. Prior to that, Vittoria held operational and scientific roles in clinical R&D, in the pharmaceutical and CRO industry beginning 2001. Vittoria holds a master’s in molecular biology from the University of Pisa, Italy, and had basic research experience in molecular genetics and immunology at the University of Gothenburg and Karolinska Institute of Stockholm, Sweden.