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.

Hans van Bruggen has been involved in the transition form paper to digitalized paper to data exchange to data sharing. Key areas of expertise: lean regulatory documents, data capture right-first-time, and reuse rather then recreate or copy. Hans has an MSc in Pharmaceutical Medicine from the University of Surrey and has worked within, or for, the pharmaceutical industry for more than 30 years in Global or European Headquarters. Using that scientific background he brings together people, processes and tools, leading to lean interdisciplinary and international processes.

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.

Managing Director, Marr Consultancy Ltd. Recognised expert in IDMP through work in ISO, EU IDMP Task Force, Conference Speaker and numberous engagements with top 25 pharma (and other pharma clients), software houses and service providers in the e-Regulatory space.

Christian started his education at a technical school in the area of mechanical engineering before receiving a degree in biology from the University of Salzburg. He then obtained a PhD in the field of molecular biology at the Autonomous University in Madrid focusing on text mining applied to molecular biology and biomedicine where he contributed in the areas of protein-protein interactions, DNA array analysis and automatic ontology learning. Later he worked on the development of a semantic search engine for biomedical researchers and coordinated the Spanish National Bioinformatics Institute in Madrid. He joined the Semantic Web Company in 2012 as a senior consultant where he contributes to the development of the Pool Party product family.

Joyce de Langen has more than 10 years of experience within the domain of pharmacovigilance and drug safety. Having worked in both the pharmaceutical industry, academia and regulatory authorities, she developed a broad perspective and knowledge in pharmacovigilance and drug safety. She has gained experience within drug safety and IT by participating in several safety database upgrade and implementation projects. Joyce participates in the product management team of the Elsevier’s Pharmacovigilance Solution covering scientific literature monitoring, triaging and analysis and text and data mining. She is pharmacist by training and operates in Amsterdam.

Lorrie graduated with a Masters of Public Health from the University of Toronto and worked at Women’s College Hospital managing clinical trials in the osteoporosis program. She joined Roche Canada in 2003 as a Clinical Trial Monitor and held positions in Clinical Operations until she accepted the position of Global TMF Manager 2014. Prior to that, in 2011, she became part of the TMF project to redesign the processes and tools to support TMF management. During the project she had various roles including the scanning hub lead, Deployment and Adoption lead and finally project sponsor in 2015. She took on the Global Process ownership for TMF at Roche Basel in 2015 and is accountable for ensuring compliance to the TMF SOP and business process.

Júlio dos Anjos implemented databases and information products for academic and hospital libraries for 20 years before joining Elsevier 4 years ago. Since then he implemented Pharmacovigilance solutions in multiple companies. He is now the lead consultant for Pharmacovigilance in the Elsevier R&D Professional Services team. He has degrees in Library and Information Sciences as well as in IT Management.

Ms. Fallen is an authority on the business processes and associated use of information technology in drug development with a focus on regulatory and clinical. A passionate advocate for moving life sciences business on-line, Betsy is an expert on regulatory and clinical operations. Over the two decades of outstanding contributions at Merck, she was recognized for her leadership and excellent representation of the organization on internal transformational teams and in many industry initiatives. Now consulting, she continues to be recognized for her knowledge in technical innovation, process efficiency and ability to assess and assure compliance in documentation, execution and oversight.

Paul Fenton holds a degree in management from London Metropolitan University as well as an MBA in Technology Management from the Université du Québec à Montréal. Paul has significant industry experience at a senior management level in the development, deployment and management of computerized systems for use in regulated clinical trials. He co-founded Montrium in 2005. He has worked on major clinical technology projects both in Europe and North America and has a strong background in CDISC and ICH standards as well as in the integration of systems and processes for clinical trials. He is a member of the TMF Reference Model Steering Committee and co-chair of the eTMF Exchange Mechanism Standard.

Lisa has 28+ year career in the pharmaceutical industry, in the areas of Clinical Operations and Quality Management. She became an independent consultant in 2007 to focus solely on the Trial Master File management process. She assists clients with improvement of their current state and set up and use of eTMF systems. She is also experienced in the quality assessment of study-specific TMFs. Lisa is a co-founder and a current Steering Committee member of the volunteer team of industry representatives that created and maintains the TMF Reference Model. She led the team of industry representatives who recently reviewed and revised the Framework for the Destruction of Paper, v2.0 that was organized and accomplished through the DRM Community.

Vittoria leads the Clinical Documentation Operations group at GSK Pharmaceuticals R&D, accountable for the tactical implementation of a sustainable TMF delivery strategy. She transitioned from Novartis where he launched the division’s electronic TMF system and established new processes and standards in document management and archiving for quality and compliant clinical studies. She led inspection readiness programs, clinical operational excellence initiatives and contributed to the DIA TMF Reference Model working group. Vittoria holds a Master’s Degree in Molecular Biology from the University of Pisa, had basic research experience in molecular genetics and immunology at the University of Gothenburg and Karolinska Institute of Stockholm.

Dr. Stamatiadis graduated from the University of Patras with a BS in Biology and with a Masters degree and a PhD from the University of Paris VI. Subsequently, he obtained an MBA from the University “La Sorbonne”. Dr Stamatiadis has more than 25 years Pharmaceutical industry experience in Europe and the USA. In 2012 he founded MAIA Consulting based in Geneva, Switzerland. Dr Stamatiadis has a long experience in deploying enabling technologies in small and large companies. He is an active member of the DIA, a seasoned presenter and author of several articles on digital technologies in Pharmaceutical R&D.

Dr Sully is charge of the global TMF management and was formerly the regional head for clinical trials that were in Start-Up in the EMEA region. A career spanning 18 years working within the clinical operations departments of CROs, he has gained strategic and operational experience with regulatory procedures, challenges of clinical trial (CT) delivery and the evaluation of technologies for CT optimization in the start-up space. He has led INC Research through a reevaluation of the eTMF platform and advised & driven clinical system integrations of in house systems. He earned his BSc in Biochemistry & Pharmacology from Southampton University and his PhD from Imperial College London.

Senior Information Manager with a focus on the TMF Content Standards for Pfizer and has supported the use of eTMFs for more than 8 years. During this time he has supported a number of regulatory GCP inspections (primarily MHRA and PMDA) and presented eTMFs as part of those inspections. Current focus is to improve content management services to support seamless access to content across the R&D organization so that functionality guarantees quality standards for accuracy, validity & completeness while interfaces are intuitive, simple and easy to use. The overall driver being quality content for the R&D organisation.

After obtaining a PhD in theoretical linguistics, Jan worked for several start-ups in the field of artificial intelligence. Jan has worked as senior solution architect at Logica and was involved in several large-scale, high-profile innovation programs. Jan is a technology evangelist in the field of Linked Data and Semantic Web technology, and specializes in language processing, controlled vocabularies and business glossaries. Jan is currently employed as CEO of Taxonic, which he co-founded in 2012. Taxonic is a consultancy that focusses on applying Linked Data technologies to real world business problems.

Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having previously had a split inspection role between the GCP and Laboratories teams. As an Expert Inspector his role includes the provision of technical leadership, guidance and support. Jason has a degree in Biomedical Science and a Postgraduate Diploma in Pharmaceutical Technology & Quality Assurance. Previously Jason spent seven years in the UK National Health Service working in hospital pharmacy (including clinical trials & manufacturing).

Jasper is one of the consultants at the Iperion Consultancy firm specialized in the implementation of IDMP and XEVMPD at pharmaceutical companies. He has worked on these topics since 2012 from start to finish as a business architect, including activities such as data collection and quality control, system requirements specification and implementation, procedure creation and data migration projects. Jasper has a background in chemistry and innovation management, and he enjoys solving the puzzles imposed by these new requirements and regulations.

Jamie has over 18 years of IT experience in the pharmaceutical industry. She has been with BeiGene since January 2022 as the Global Head of Trial Master Management & Records. Prior to that she was with Daiichi Sankyo, Inc., for over 5 1/2 years. She is a Steering Committee member of the DIA TMF Reference Model Working Group and on the Operations Committee and a Director for the Health Sciences Records and Archives Association (HSRAA). She also serves on the AVOCA Safety Leadership Advisory Board. Jamie is a Certified Project Manager (CPM), a trained Six Sigma Green Belt, and is PROSCI certified.

Joel became embroiled in electronic submissions when regulatory came downstairs and asked "Can we convert all our reports into WordPerfect format for the FDA reviewer?" -- and he didn't say "no." Since then, he's been involved with content management, custom CANDAs, PDF publishing, eCTD, document template automation, Regulatory Information Management, HL7's RPS, and the ISO IDMP standard both as a vendor/consultant and within biopharma companies.

Jim has nearly 30 years of experience with compliant software solutions for regulated processes in both the insurance and life sciences industries. He has held senior management positions at Intracorp (a CIGNA company), Liquent, Thomson Reuters, ePharmaSolutions, DitaExchange and Cunesoft. Following the merger of Cunesoft into Phlexglobal, Jim is now the Chief Product Officer at Phlexglobal. Phlexglobal is now part of Cencora PharmaLex. Jim holds a Bachelor of Science in Mathematics from The Pennsylvania State University.

Mickel Hedemand is Special Adviser at the Danish Medicines Agency (DKMA) where he has been working for 11 years. He is managing DKMA’s electronic format requirements and procedures for receiving, technically validating, registering and archiving submissions in the medicines regulatory area. This also includes maintaining tools and processes supporting these activities. Among other things he is an active member of EMA’s Human Harmonisation Maintenance Group and has put his footprint on the technical validation criteria and the harmonised eCTD and NeeS guidances. He has an M.Sc. in Engineering and a past history as an IT consultant.

Pierre has developed and managed IT solutions for life science for the last 15 years. He has been involved in all steps in the life cycle of industrial systems. He develops new solutions using cutting edge technologies for regulatory, clinical, quality and pharmacovigilance systems. His expertise ranges from numerous generic technologies to business related systems. Before Ennov, he has worked with technology companies, ITomics and Valigen and in a fundamental research laboratory (Pasteur Institute) where he has developed text-mining tools to leverage information from vast corpus of biomedical literature. He has an engineer diploma from French ‘Grandes Ecoles’ and studied at the University of Illinois, Urbana Champain, USA.

Georg Neuwirther, Head of IT Austrian Medicines and Medical Devices Agency (AGES MEA), Chair of the eAF Maintenance Group, Co-Chair SPOR Taskforce since December 2021. As Head of IT at AGES MEA, he is responsible for the agency's IT strategy and IT portfolio management, with a focus on solutions that enable innovation in business processes. This includes efficient data and process integration in EU initiatives. As a result, Mr Neuwirther introduced a new IT system called PHAROS, which replaced legacy systems. This flexible solution is the basis for ongoing and further national developments and integration into Europe-wide initiatives such as the implementation of CTIS, UPD, SPOR and others.

Braun’s 25-year career to-date has been spent across roles related to Compliance, Document Management, Content Management in the Life Sciences industry – both on the client side and in consulting, spanning delivery, sales, project and line manager roles. His experiences bridge on-premise and cloud environments, in Europe and in US. Braun holds a Master’s degree in Drug Regulatory Affairs from the University of Bonn (Germany) and his diploma in Data Technology from the Technical University (TU) Darmstadt (Germany)

Jens Ergueden began his career at Bayer in 1999. After positions in Med Chem Research and Quality Management, he changed to Bayer´s Pharma R&D Information organization in 2007, where he took over system owner responsibility of the central R&D electronic archive system. Jens joined Pharma Regulatory Affairs in 2011, where he heads a group in the Document Management department. His current responsibilities include governance of the global R&D EDRMS, and managing the global archiving processes of Regulatory documentation as well as of paper TMF.

Matthew is CTO and Founder of Arkivum. Over the last fifteen years, Matthew has worked with a wide range of organisations in the UK, Europe and US on solving the challenges of long-term data retention and access. Sectors include higher education, healthcare, lifesciences, aerospace, broadcasting, heritage and memory institutions. Expertise includes digital preservation strategies, system architectures, total cost of ownership, how to mitigate the risk of loss of critical data assets, and building business cases for both compliance and asset value scenarios.

Jillian Carinci is Sr. Director, Head of Submission Sciences group at Biogen. Jillian leads Biogen’s Global Delivery Managers and is responsible for overseeing global submissions, establishing processes, ensuring compliance, robust submission planning, tracking metrics, high quality submission delivery and process improvements. Jillian began her career at Octagon Research Solutions before transitioning to Accenture. During her tenure at Accenture Jillian partnered with sponsors to manage numerous regulatory submission projects, ensuring compliance with global regulatory requirements, delivering within scope, on time, and with the highest quality.

Klaus Menges is currently leading a BfArM project replacing an old database on products by an IDMP compatible data base, contributing to the PharmNet.Bund portal, the German platform for medical products providing information to the general public, and services for pharmaceutical companies and regulators. Klaus represents BfArM in the eSubmission Change Management Board (eSub CMB) and is nominated expert in the ICH WG M8 on electronic submission.

Mr. Vanggaard is a strong team player and a results-driven senior Life Sciences R&D consultant with 9+ years of experience within Clinical Development and Regulatory Affairs implementing Clinical Data Warehouses, Meta Data Repositories, Clinical Trial Management Systems, Electronic Trial Master Files and helping more than 5 clients prepare for IDMP implementation. In addition, Mr. Vanggaard is working closely together with the HighPoint Solutions Master Data Management Practice Lead on developing an MDM-based IDMP accelerator leveraging one of the leading platforms on the market and capable of handling unstructured data from documents.

Catherine provides expertise in RIM strategies, XEVMD, IDMP and Master Data Governance. Drawing on her proven expertise in project management across Regulatory Affairs and in advancing processes across R&D, she provides consultation on comprehensive RIM systems configuration & implementation strategies for migration and data harmonisation. She has co-lead a major RIM project for a large company, defining the scope across a complex product portfolio incl. Medicinal products, OTC, Medical Devices and implementing a data governance supporting data quality framework. Before joining ProductLife Group, she was Director of Regulatory Informatics and Submission Management at Merck Serono. She is a Chemistry Engineer from the University of Lyon.

Frits Stulp is Managing Director of Iperion a Deloitte business, with over 20 years of industry and consultancy experience. In this role he leads a team of regulatory / IDMP experts active in various projects to deliver value to both pharmaceutical companies as well as regulators. Frits is the IDMP topic group lead for the IRISS Forum and heavily involved in the EU-SRS project for the Medicines Evaluation Board / European Medicines Agency as part of SPOR landscape. Frits is also Chariman of the Board of CTADHL, involved in Transatlantic adoption of IDMP (www.ctadhl.org). Regarded as an SME on IDMP, he gladly shares his gained knowledge and experience in various occasions around the globe.

Michiel has 15 years of experience in Regulatory Affairs and Information Management. He provides strategic direction and subject matter expertise for implementation of Regulatory Information Management (RIM) solutions. His focus goes beyond compliance, Michiel specializes in unlocking the true value of an organization’s data – whilst taking advantage of initiatives such as XEVMPD, IDMP and SPOR. Through the alignment of people, cross-functional processes, and tools, he has enabled efficient and sustainable data quality for a wide range of customers.