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Hotel Holiday Inn

May 23, 2016 9:00 AM - May 23, 2016 5:30 PM

Haagse Schouwweg 10, 2332 KG Leiden, Netherlands

TUTORIAL 1 - ELECTRONIC TRIAL MASTER FILES (ETMF) – MORE THAN A DOCUMENT REPOSITORY

Instructors

Eldin  Rammell

Eldin Rammell

Head of Quality Assurance, Phlexglobal Ltd, United Kingdom

Eldin began his records management career in 1986 at Glaxo. He held a variety of information and records management positions of increasing seniority, which continued following his move to Pfizer in 1993. His experience spans most areas of information and records management. In 2004, Eldin established Rammell Consulting, a management consultancy specialising in the provision of records management support, primarily to the pharmaceutical and biotech industries. He is a recognized expert globally in the area of trial master file management, completing over 30 TMF-related consulting projects and being a Steering Committee member of the TMF Reference Model Project.

Karen  Roy, MPharm

Karen Roy, MPharm

Chief Strategy Officer, Phlexglobal, United Kingdom

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.

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