Bio Kristen has worked for 20 years in the pharmaceutical industry. She presently serves as a Document Center Manager at PSI Pharma Support America, Inc. in charge of Trial Master File operations for the U.K., Australia, New Zealand and North and Latin America. She has spent a great portion of her time working on bridging the gap between sponsor and CRO expectations in TMF functionality as well as assisting in the development and deployment of client based eTMF services for her current company. She is a recognized expert in the field of clinical Trial Master Files and specializes in finding customer orientated solutions to risk management and compliance in a global environment.
Martina Duevel – Systems Excellence Project Leader
Martina Duevel has almost 20 years of pharma experience. In her current role as Systems Excellence Project Leader at Bayer she is responsible for eTMF Innovation and its integration into the R&D system landscape and involved in other projects driving digitisation. In 2015 she lead the implementation of Bayer's eTMF and subsequently headed the maturation program.
Martina has started her Industry career in Clinical Quality Assurance where she worked as an auditor for studies, vendors, and systems, as trainer of auditors and as internal GCP consultant for process changes, inspections, and SOP development. In 2008 she moved into Clinical Project Management were she was overseeing operations for clinical development projects in oncology and diagnostic imaging from early planning through submission and inspection. In 2014/15 she led a group of clinical trial coordinators and clinical records coordinators managing study TMFs.
Martina has studied Biochemistry and earned a doctorate (Dr. rer. nat) from Free University Berlin and worked in several research institutions were she gained her first GxP experience. She is a certified Project Manager as well. In her spare time she enjoys spending time with her family, singing in a choir, and gardening.
Associate Director, Document Control and Training- DYNAVAX TECHNOLOGIES
Robin Farmer – Associate Director, Document Control and Training
Robin has over 15 years’ experience working directly in the Records Management space. She gained her experience working as a paper TMF processer at Amgen. Within that role she was able to gain the experience of transitioning from a paper based system to an eTMF system.
For the past 7 years Robin has held positions of leadership in various roles and worked with companies managing TMF records on various projects that range from: mergers and acquisitions, converting paper TMF to eTMF, helping records teams organize their work space to be more productive and create better process flows, as well as inspection readiness activities.
In her current role she owns the eTMF process and works closely with CRO vendors to help maintain a contemporaneous eTMF. She also manages documents outside of the TMF such as Clinical Operations Training records and non-TMF documentation for proper storage.
Robin received her Doctorate from the University of La Verne in 2013 with a focus in Organizational Leadership and Management. Her dissertation, entitled: Elements of Teamwork in Biotechnology Companies focused on the need for strong leadership practices within the Biotech workspace.
IT Business Partner Clinical- BAYER BUSINESS SERVICE GMBH / BAYER AG
Christoph Gerdts holds the position of an IT business partner for Clinical R&D at Bayer Business Services GmbH / Bayer AG. In his present role he serves as an advisor driving the embedment of IT solutions into clinical operation and strategy from ideas to projects enabling digital transformation.
In regard to eTMF Christoph and his team have been responsible for implementing Bayer’s eTMF solution in 2015 and since then drive innovating and maturing the eTMF solution and strategy.
Christoph has started his career in the pharmaceutical industry in 1990. Prior to his present position he held different roles in IT and business organization in R&D. Among others supporting Clinical Development, Drug Safety, Medical Affairs and Marketing functions in leading consulting positions. He has been responsible as System Owner for different applications supporting the planning, reporting and documentation processes in these areas. As an operational role he also headed the Information Services Function in the Business Unit Women’s HealthCare at Schering AG for a number of years.
Christoph holds an M.S. in Medical Informatics from the University of Heidelberg.
Head of Global Documentation Quality Centre EU- BOEHRINGER INGELHEIM
Martin Hausten – Head of Global Documentation Quality Centre EU
Martin Hausten has been with Boehringer Ingelheim (Germany) since 2004.
He facilitated the set up of the BI TMF Governance Structure starting in 2013 and has been the Chair of the TMF Governance Committee since 2015, a global team of TMF SMEs, business process owners and Global Document Quality Centre leads.
Since March 2016, Martin has been the Head of the Global Document Quality Centre and has led the German team of Global Document Quality Specialists. He is active in the development, implementation and maintenance of Trial Master File (TMF) strategies.
He is experienced in setting up and maximizing outsourcing efficiency and efficacy models and best practices pertaining to TMFs.
Martin collected deep insight into clinical trial processes and CROs' quality management systems during his role as a GCP Auditor and Project Compliance Manager. Before that he was responsible for applying Computer System Validation Standards to systems used in GCP and GMP environments.
Martin studied Business Administration (Dipl. Betriebswirt), is a certified Auditor (DIN EN ISO 19011) and a certified Quality Manager (ISO DIN EN ISO 9000 family), and likes to practise sports.
Senior Manager Process Quality, Clinical Medical Quality- GSK VACCINES
Susan Homminga – Senior Manager Process Quality, Clinical Medical Quality
Susan has over twenty years of experience in the pharmaceutical industry in global positions at different sponsors in the Netherlands. She gained her experience in R&D documentation and in clinical operations as CRA and clinical project manager. In parallel, Susan was involved in process improvement and training initiatives related to clinical development.
The last five years Susan is part of the quality organization and is (among others) overseeing the TMF process. In this role, she is involved in improvement projects for TMF, like updating the SOPs and associated documents around the TMF process, a security enhancement project and most recently in the implementation of a new TMF system.
Furthermore, Susan is, as part of a temporary assignment, part of the TMF team and acting as TMF CAPA lead, where she is collaborating with the business to improve the TMF compliance. She holds a Master of Science in Biology at Groningen University (NL) and a Master of Science in Educational Science and Technology at Twente University (NL).
Andreas Järemo is Associate Director Enablement with AstraZeneca where he is the TMF Global Lead overseeing the framework of the enterprise-wide TMF. In this role, he interacts with internal senior leaders, internal science unit’s implementation leads, external vendors, projects and study teams to make sure that the process, system, and central services set up are in line with expectations and current regulations.
Andreas has more than 20 years of Pharma Industry experience, spending most of his time in AstraZeneca. With a research background in Immunology, Andreas has had several positions as study leader, both globally and locally including monitoring. He has been working with patient safety, authoring protocols, leading phase I to III studies and various improvement projects. Andreas then continued to conduct outcome trials implementing study set-ups and integrations, defining process and systems, and working with CROs and AROs.
Tracey McCulloch – Head TMF Operational Excellence
Tracey McCulloch has 20 years of clinical research experience in both Pharma and Biotech. Currently in her role as TMF Operational Excellence Head, she is accountable to build the TMF Operational Excellence team, define and implement the global strategy for electronic and paper trial master file inspection readiness, training, communication, and user engagement.
Tracey joined Novartis in 2006 and has held several roles of increasing responsibility in Data Management and Trial Management. Recently, Tracey led the Novartis process creation, integration, monitoring and reporting of Quality Tolerance Limits (QTLs) in Clinical studies, in compliance with the updated ICH E6 (R2) guidelines. Tracey completed her Six Sigma Green Belt training that focuses on teaching individuals the methods to lead and embed a culture of change and continuous improvement in business practices. Prior to working at Novartis, Tracey worked at Bayer, Merck Frosst Canada and Sanofi. Tracey received a Master of Science degree in Neuromuscular Physiology from the University of Montreal.
Head eDMS Center of Excellence/Regulatory Readiness- NOVARTIS
Timothy Rafferty – eTMF Quality and Metrics Manager
Tim Rafferty works at Roche in the Pharma Development eTMF Team. His main responsibility is to provide metrics around the use of the system by the Trial Teams. This means a focus on measuring the effectiveness of the many processes involved throughout a trial’s life cycle. He works closely with the business process owners to ensure that KPIs are monitored and met and that senior management are aware of any significant variances.
He has developed a suite of sophisticated near real-time dashboards, which have been instrumental in driving forward data quality. He has also worked closely with Process Management and Business Change Management streams to ensure that new approaches to the eTMF are widely adopted. Prior to his current role Tim worked in Regulatory Governance at Roche.
Director- HEALTH SCIENCES RECORDS & ARCHIVES ASSOCIATION
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, including: DMSs and ERMS/EDMSs; file plans and retention schedules; classification schemes and taxonomies; microfilming; disaster recovery; data protection; imaging and workflow solutions; mergers and acquisitions; litigation support; change management; archive and active file management. In 2004, Eldin established Rammell Consulting, a management consultancy specialising in the provision of expert records management support, primarily to the pharmaceutical and biotech industries. He has worked with several companies on the development and implementation of eTMF systems and supporting processes.
TMF Repository Support Lead, TMF Governance Office- NOVARTIS
Edith Tapie – TMF Repository Support Lead, TMF Governance Office
Edith Tapie has held various roles in the TMF management from paper archiving to electronic TMF system areas over the last 13 years working in Novartis.
For paper archiving, she developed procedures to better control, track and enhance quality of paper TMF shipments received. She built and supervised CRO processes to improve documents quality ensure sponsor oversight and timely transfer of paper and electronic documents.
As TMF importing tool system owner, she established an electronic TMF documents naming convention standards to ease the access and retrieval of TMF documents in the main TMF system.
To provide TMF owners with the means to better comply with TMF Requirements, Edith Tapie led recently the implementation and rollout of a new application to access and review the TMF documents from a virtual structure based on TMF Reference Model one including reporting, alert notifications and document location indication functionalities. Edith Tapie is currently working on integration and/or interfaces of the different Novartis TMF Repositories to streamline and facilitate access to the TMF throughout the company according to Health Authorities TMF expectations.
Director and Head of TMF Operations- DAIICHI SANKYO
Ms. Toth has over 18 years of IT experience in the pharmaceutical industry. She has been with Daiichi Sankyo, Inc. since 2016 as the Director/Head of TMF Operations; prior to that, she worked at Covance for 8 years within the Trial Master File space.
Ms. Toth is a Steering Committee member on the DIA TMF Reference Model Working Group and on the Operations Committee and a Director for the Health Sciences Records and Archives Association (HSRAA).
Ms. Toth is a Certified Project Manager (CPM), a trained Six Sigma Green Belt, and is PROSCI certified. She received her Master’s Degree in Clinical Research & Organizational Management from Drexel University, a Bachelor of Arts in Business and Technology from Fairleigh Dickinson University, and has an Associates of Applied Sciences in Computer Systems & Technology from Mercer County Community College.
In her spare time, she enjoys family time and watching her kids play soccer, basketball, and football.
Principal Competency Development Specialist- NOVO NORDISK
Anne-Mette Varney – Principal Competency Development Specialist
Anne-Mette Varney is working as a Principal Competency Development Specialist and TMF Process Manager within Trial Management Anchor, 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 collaborate cross functional. Since 2012 she has been LoB PM in TMF Improvement Project optimising the TMF process and Inspection Readiness, supported a TMF IT Project as TMF process expert, conducted pilot on centralised QC and oversight, and leading the change process implementation in the global organisation. As background Anne-Mette holds a bachelor in Nursing and worked as a nurse for several years before moving to Pharmaceutical industry in 2000. During the past 18 years she has been working within Safety and Pharmacovigilance, Project and Program Management in CRO, and Clinical Operations as Senior International Trial Manager and TMF Process Manager.
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