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\nDirector Regulatory Information Management Qdossier-A Celegence Company, Netherlands  \nKaren McCarthy Schau  \nDirector, Risk-based Study Management Vertex Pharmaceuticals  \nStacy Tegan  \nAssociate Director, Program Management Transcelerate Biopharma Inc.  \nEthan Chen, MBA, MS, PMP  \nDirector, Division of Data Management Services and Solutions, OBI, OSP  \nCDER FDA  \nPROGRAM COMMITTEE  \nJake Doran  \nHead of Digital MAPS Public Benefit Corporation  \nJo English  \nVice President, Regulatory Information Management Calyx, United Kingdom  \nVahe Ghahraman, PhD  \nSenior Director, Global Regulatory Operations Head Apellis Pharmaceuticals, Inc.  \nKristen Sauter, MBA  \nDirector, Global Regulatory Informatics & Analytics Takeda Pharmaceuticals  \nCary Smithson, MBA  \nDirector Regulatory Solutions Phlexglobal  \nKatherine Novak, MS  \nSenior Advisory Consultant, Life Sciences  \nNNIT  \nAlison Buno, MBA  \nSenior Director, Regulatory Submissions  \nAbbvie, Inc  \nJoanne Malia, MS, MSc  \nDirector, Clinical Documentation Management Regeneron Pharmaceuticals  \nJamie O’Keefe  \nHead, Clinical and Regulatory Consulting Services  \nAstrix  \nJoel Finkle  \nAssociate Director, Regulatory Information Management BeiGene  \nSandra Krogulski, MA  \nDirector, GRSO Innovation and Business Operations Lead Bristol-Myers Squibb Company  \nRob Labriola, MS  \nExecutive Director, Regulatory Operations  \nSynchrogenix  \nDaniel Offringa  \nPrincipal Consultant eSub Solutions  \nJonathan Resnick, PMP  \nProject Management Officer, OBI, OSP  \nCDER FDA  \nOverview  \nThe last few years have shed light on the importance of operational efficiency of the management of regulatory information to ensure quality regulatory submission to health authorities. We have seen how the ability to perform at this level has allowed drug companies to bring therapeutics and vaccines to patients faster. At DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) Forum, we will hear from industry and regulatory stakeholders working across the scope of regulatory information to examine current and evolving data standards and requirements and effective regulatory information management approaches to align related people, processes, and technology. The Forum presents four tracks: Regulatory Informatics Business, Regulatory Informatics Technology, Trial Master File (TMF) Inspection Readiness and Electronic Document Management, and Electronic Regulatory Submissions. Cross-track sessions provide the opportunity to discuss key connection points across major components of regulatory information, and plenary sessions featuring regulatory intelligence updates by FDA and other regulatory authorities are offered each day.  \nThis Forum provides multiple opportunities for networking, knowledge sharing, and education for both business and technology-focused attendees.  \nEvent Goals and Offerings  \n• Gather insights to hot topics impacting regulatory information in life sciences research and development  \n• Hear directly from global regulators on regulatory plans, priorities, and updates to incorporate into your everyday work and processes  \n• Identify how advanced technologies and innovation can be applied to impact functions and processes within regulatory affairs  \nWhy You Can’t Miss it  \n• Network with like-minded professionals focused on regulatory information in life sciences research and development to discuss best practices and lessons learned  \n• Learn how to apply successful use cases, real-world examples, and practical outcomes into your own company or organization  \n• Gain insights and discuss how stakeholders are impacted by everyday challenges and how they overcome these challenges  \n• Evaluate future applications of regulatory informatics, trial master file inspection r","cbCaigZz1rIk1sPS","https://ap.wps.com/l/cbCaigZz1rIk1sPS","pdf",1615097,"English","# Overview\n## Event Goals and Offerings\n## Why You Can’t Miss it\n## Meeting Designed for\n## Schedule-At-A-Glance\n## Virtual Short Course","[{\"question\":\"What is the RSIDM Forum focused on?\",\"answer\":\"The Forum focuses on regulatory information management across people, processes, and technology, including evolving data standards and requirements to support quality regulatory submissions.\"},{\"question\":\"What tracks are included in the Forum?\",\"answer\":\"It includes four tracks: Regulatory Informatics Business, Regulatory Informatics Technology, Trial Master File (TMF) Inspection Readiness and Electronic Document Management, and Electronic Regulatory Submissions.\"},{\"question\":\"Who should attend the Forum?\",\"answer\":\"It is designed for regulatory affairs and operations roles, regulatory information management and informatics professionals, submissions and project management teams, writers, TMF/eTMF managers, IT/support personnel, and document and records management specialists.\"}]","Regulatory Submissions, Information, and Document Management Forum - PROGRAM CO-CHAIRS | PDF",1789130192]