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 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.

John has 30 years’ experience in the biopharma industry. He has held global leadership positions in R&D IT, IT Shared Services and Chief Technology Officer roles, and been responsible for the delivery of major technology enabled organisational transformations in Regulatory, Pharmacovigilance, Clinical, Medical Affairs, IT and Global Business Services. These solutions have included Content Management, Publishing, Medical information, Safety, CTMS, Business Intelligence, Business Process Management, NLP, NLG, Machine Learning and AI. John has worked for and with many of the Top biopharma companies throughout his career and holds a BSc in Chemistry and an MBA from Warwick Business School.

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.

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.

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.

Francis P. Crawley is the Executive Director of the Good Clinical Practice Alliance – Europe (GCPA) and the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) in Brussels, Belgium. He is a philosopher specialised in ethical, legal, and regulatory issues in health research, having taught at several European, Asian, and Middle East universities. He is an expert in ethical review, data protection, and data sharing. He is a Data Protection Officer (DPO) on European Commission funded clinical research programmes. He currently chairs the methodologies sub-group of the Real Word Data Working Group at the Faculty of Pharmaceutical Medicine, Royal Colleges of Physicians.

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.

René Kasan is a senior management consultant and subject matter expert for computerized systems in the pharmaceutical industry. In addition, he is founder and CEO of 37 Centigrades AG, a consultancy located in Zug, Switzerland with focus on providing IT-related services to the life sciences sector. Mr. Kasan has an elaborate record of accomplishment not only working as specialist and lead auditor on GxP compliance topics but also as business analyst in the area of RIM. Mr. Kasan holds a diploma degree in computer sciences of Technical University Berlin, a post-diploma degree in business administration of Technical College Berlin, and an M.B.A. of Daniels College of Business / University of Denver, Colorado.

Life sciences R&D Ecosystem Expert, Independent Small Business and Workforce Advocate, Software Platform Developer and Investor. Focus areas include: Regulatory and Clinical Operations, Strategic Patient Engagement, CMC, Real World Evidence, Pharmacovigilance, and Biometrics, Medical Affairs, Market Research, Medical Writing, Data Management, Discovery, Toxicology, Pharmacometrics and Pharmacology, and all of the technology that enables these functional areas, others. Actively creating crypto for organizations in the form of LifeSciHub, a nascent Decentralized Autonomous Organization. Exactly how crypto has upended traditional currency in incredible ways, DAO is a new way that groups can create value outside of hierarchical structure.

Doug is a partner at Deloitte Switzerland, one of the fastest growing member firms within Deloitte’s global network, providing Audit & Advisory services to national and global clients. Doug leads the Regulatory solution offerings in the Life Science and Healthcare sector for the Risk Advisory practice. He is a specialist within the Life Science industry with extensive experience working to board level with clients across Europe and teams on tracing the impact of legislation and regulatory requirements through to strategy, design and implementation. He gives particular emphasis to innovative offerings transforming Regulatory functions that drive business performance.

Remco Munnik is a Director at Iperion, a Deloitte company. He has more than 20 years’ experience in Life Science and Regulatory Affairs, including more than a decade providing consultancy around Regulatory Information Management (RIM) and electronic submissions. He is a respected subject matter expert in RIM, eCTD, xEVMPD and ISO IDMP. Remco is Chair of Medicines for Europe Telematics group; and President of the IRISS Forum, a global, open, multidisciplinary, non-profit networking organisation for life science professionals by life science professionals.

Barry Sacks is the Chief Technology Officer at Phlexglobal. Barry was previously a Partner within Digital Works Group’s Product, Project and Technology team bringing over 25 years of experience leading a variety of start-up, SME and blue-chip organizations through the design, delivery, management and growth of innovative digital products and services. An accomplished technology entrepreneur, corporate director and consultant having worked throughout the UK, Europe, Australia and the US. Prior to Digital Works Group, Barry founded a SaaS venture, was the Global CTO for the FinTech MyJar, the CTO (Corporate Venturing) for Diageo, as well as enjoying a varied interim career.

Dr Peter Lassoff Pharm.D., FTOPRA, has over 30 years’ experience within global regulatory affairs and is the Senior VP, Regulatory Affairs, for Syneos Health. Peter has deep domain expertise in regulatory affairs and drug development, and has established and grown businesses in the regulatory outsourcing sector on a global basis. Peter is a Fellow of TOPRA, the professional society for regulatory affairs; is on the Board of Supervisors for the University of Southern California's regulatory affairs programme, and has won a lifetime achievement award for regulatory affairs, the Innovation in Regulatory Science Award at the USC School of Pharmacy.

Niamh has 23 years’ experience in the Global pharmaceutical industry spanning Pharmacovigilance and Regulatory. She has held a variety of functional and project roles including leading the Regulatory Documentation Group accountable for driving the content strategy and preparation of documents needed for regulatory submissions that support the development and maintenance of product licenses. Currently as Capability Development Leader she is responsible for delivering strategies to transform the preparation of Regulatory Submissions across the product lifecycle. Niamh has developed a passion for the importance of data management in transforming regulatory processes and the value that regulatory data can bring to the organization.

Laura holds a Master’s degree in Biomedical Engineering and a Ph.D. in Applied Mathematics from the University of Liège, Belgium. She joined CluePoints in 2015 and moved into her current role as R&D manager in 2018. Within CluePoints, Laura is leading a team of data scientists responsible for developing new statistical and Machine Learning algorithms to assess the quality, accuracy, and integrity of clinical trial data. These algorithms are at the core of CluePoints Monitoring Platform used by Sponsors, CROs and Clinical Technology Organizations to drive Risk-Based Monitoring (RBM) and Data Quality Oversight.

Working as a Regulatory Operations Manager since 2012 for Qdossier B.V. He’s an experienced professional with expertise in Pharmaceutical Industry and has a proven ability to solve problems, communicate and manage all Regulatory Operations within specified timelines. At Qdossier Armand is a Senior Regulatory Operations Manager with experience in Regulatory Affairs, Data Management, Submission Management and planning and Global Dossier building in various formats and regions. He has managed and prepared several dossiers for Initial Marketing Authorisation Applications, Paper to NeeS-NeeS to eCTD baselines and hundreds of submissions. He’s also knowledgeable about ICH Guidelines, EU Directives and Regulations in Regulatory Affairs.

Gordon Elger has over 30 years of experience in pharmaceutical regulatory affairs, research and development. His knowledge of regulatory affairs spans across different European and international regulatory territories and he is well-versed in current good manufacturing practices, good laboratory practices and good clinical practices. Gordon has a thorough understanding of all aspects of regulatory affairs together with the pharmaceutical development process and electronic common technical document (eCTD) requirements and electronic submission methodologies.

With 10 years’ experience within the pharmaceutical industry as a project and programme manager. Nearly 20 years in IT project management. As a programme manager at EMA he led the IDMP programme creating a strong team across 32 ISO member countries and the ICH regulatory jurisdictions. As CDISC Head of European Operations Paul lead many data standards centric projects in regulatory and translational research, including CTR, Biovacsafe, and IMI eTRIKS where he managed the development of translational research systems across genomic and clinical data and developed the strategy for open linked data systems and industry data lakes. He is proficient in PRINCE 2, Scrum, XP and agile methods.

Director of Clinical Operations at LMK Clinical Research Consulting, owning TMF Consulting and Services Company. She is a Lean Six Sigma Green Belt certified clinical research professional with over a decade of experience in clinical trial coordination and process improvement in the healthcare, biotech, and pharmaceutical industries. For the past five years, her dedicated focus has been on the Trial Master File (TMF). Her experience includes oversight of electronic TMF (eTMF) implementation, coordination of a large migration and integration projects, development of robust metrics and training programs, enhancement and development of TMF processes, and extensive inspection readiness preparation for FDA, MHRA, and PDMA inspections.

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.

David Ross has led enterprise projects at AstraZeneca and Abbott Labs. He implemented enterprise solutions at AZ for cross-functional CSR Initiative, led the PQ/CMC pilot for AZ, developed roles for Early Clinical Authoring and leads Clinical Study Start up improvements in alignment with EU CTR 2022. He has delivered strategic and process improvements in labelling, CMC and Non-Clinical. He led the first eCTD Implementation in AZ. He is AZ representative of the PhRMA Regulatory IT Knowledge Group. He leads the GSO IRISS IRISS Forum, and is the AZ PhRMA IT group representative. He holds a B.SC in Biochemistry and a BASc. in Chemical Engineering. His graduate degrees include an MBA and Engineering Management from University of Ottawa.

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.