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 Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as CSO, she leads all Phlexglobal partnering across the clinical space, has key strategic input into the development of our eTMF, PhlexEview and serves as a Board member.
Karen was also responsible for the development of the TMF Reference Model, an industry driven initiative to standardize the content, naming and structure of Trial Master Files. She still chairs the management of the Model – a Model used by the vast majority of Pharmaceutical companies and CROs.
Karen graduated as a Pharmacist in South Africa and entered the Pharmaceutical Industry working for Eli Lilly in Sales. In 1992, she moved into Clinical Research in the UK with Chiltern International, initially managing the Clinical Development Department. Latterly she started up and globally managed a novel group, EDC Solutions, before joining Phlexglobal.
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.
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 Pharma R&D Projects, Clinical Platforms and Sciences
Vittoria Sparacio heads up the Clinical Documentation group at GlaxoSmithKline Pharmaceuticals R&D and leads the electronic Trial Master Files implementation program. In her role, she provides strategic direction for evolving the clinical document management space in GSK Pharmaceuticals R&D.
Vittoria previously held clinical research and document management roles at GSK Biologicals, Novartis, Chiron, MSD, and ICON beginning in 2001.
Vittoria established the electronic TMF system and set new processes and standards that transformed document management and archiving capabilities for Novartis Vaccines clinical development. She also led inspection readiness program, clinical operational excellence initiatives and was an early member of the TMF Reference Model working group.
Vittoria is a speaker and advisory board member for TMF conferences and seminars and is a faculty member of the Master Program in Vaccinology & Pharmaceutical Clinical Development from the University of Siena, Italy since 2009. Vittoria holds a master’s in biochemistry & molecular biology from the University of Pisa and had basic research experience in molecular genetics and immunology at the University of Gothenburg and Karolinska Institute of Stockholm, Sweden.