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Overview

Short Course: February 9, 2023 | Virtual

Short Course: February 10, 2023 | Virtual

February 13-15: Forum


The 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.

This Forum provides multiple opportunities for networking, knowledge sharing, and education for both business and technology-focused attendees.




Participant Testimonials

“Extremely useful event for any regulatory professional, or vendor providing solutions in the space. Unique opportunity to discuss solutions and industry topics with others in the industry. Can't recommend the event highly enough.” - Paul Ireland – DocShifter

“Experts from all over the world generously shared their experiences, their lessons learned, and their recommendations for what we can do now and into the future. I highly recommend this event!” - Regina Lynn Preciado, Content Rules, Inc.

  • Meeting Designed For

    • Regulatory Affairs and Operations
    • Regulatory Information Management
    • Regulatory Informatics
    • Submissions and Global Submissions Management/Project Management
    • Medical, Technical, and Regulatory Writers
    • TMF and eTMF Management
    • Informatics/Bioinformatics Professionals
    • Document and Records Management/Specialists
    • Essential Document Process and Business System Owners
    • Regulatory Standards Implementation Specialists and Associates
    • Clinical Operations and Processes
    • Quality Management
    • Quality Assurance/Quality Control and Compliance Professionals
    • Strategic Planning and Operations
    • Contract Research and Service Support Providers
    • Emerging Pharmaceutical/Biotech/Device Professionals
    • Outsourcing/Clinical Outsourcing
    • Vendor Relationship Managers
  • Learning Objectives

    At the conclusion of this activity, participants should be able to:
    • Explain and gain insights on regulatory updates from global regulatory health authorities
    • Apply insights from the PDUFA reauthorization and explain selected key data standards initiatives for the US
    • Describe eCTD v4.0 and its implementation in various regions
    • Identify KPI metrics to demonstrate RIM performance and describe a valuable roadmap to high RIM performance
    • Identify how advanced technologies can be applied to impact functions and processes within regulatory affairs
    • Describe the key requirements for regulatory submissions in Brazil, China, Europe, Japan, and the US
    • Recognize common electronic submission errors and identify tools and techniques to avoid and/or solve them
    • Describe and understand how team collaboration and an effective team strategy achieve submission goals
    • Describe the practicalities and benefits of structured content management
    • Identify practical aspects of implementing content authoring automation for regulatory submission documents and the process improvements needed to streamline those processes
    • Apply insights and implementation guidelines to increase IDMP adoption success
    • Discuss approaches for implementing and scaling intelligent automation technologies, the value in doing so, and how to deal with challenges along the way
    • Evaluate the impacts of digital transformation on the regulatory workforce
    • Evaluate how to gain intelligent insights from aggregated data
    • Describe the key elements of establishing a data governance program, the approaches to data unification and its sustainability without system integration, and the impact of implementing RIMS with poor data quality
    • Describe the current deliverables and the latest developments on ICH M11 guideline, protocol template and technical specification.

Program Committee

  • Michiel  Stam
    Michiel Stam Director Regulatory Information Management
    Qdossier - A Celegence Company, Netherlands
  • Karen  McCarthy Schau
    Karen McCarthy Schau Director, Global Clinical Operations
    Vertex Pharmaceuticals, United States
  • Stacy  Tegan
    Stacy Tegan Associate Director, Program Management
    Transcelerate Biopharma Inc., United States
  • Ethan  Chen, MBA, MS, PMP
    Ethan Chen, MBA, MS, PMP Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
    FDA, United States
  • Jake  Doran
    Jake Doran Head of Global R&D IT
    Bausch Health, United States
  • Jo  English
    Jo English Vice President, Regulatory Information Management
    Calyx, United Kingdom
  • Vahe  Ghahraman, PhD
    Vahe Ghahraman, PhD Senior Director, Global Regulatory Operations Head
    Apellis Pharmaceuticals, Inc. , United States
  • Kristen  Sauter, MBA
    Kristen Sauter, MBA Director, Global Regulatory Informatics & Analytics
    Takeda Pharmaceuticals, United States
  • Cary  Smithson, MBA
    Cary Smithson, MBA Director Regulatory Solutions
    Phlexglobal, United States
  • Katherine  Novak, MS
    Katherine Novak, MS Senior Advisory Consultant, Life Sciences
    NNIT, United States
  • Alison  Buno, MBA
    Alison Buno, MBA Sr. Director, Regulatory Submissions
    Abbvie, Inc., United States
  • Joanne  Malia, MS, MSc
    Joanne Malia, MS, MSc Director, Clinical Documentation Management
    Regeneron Pharmaceuticals, United States
  • Jamie  O'Keefe
    Jamie O'Keefe Vice President, Business and Technology Consulting
    Just in Time GCP, United States
  • Joel  Finkle
    Joel Finkle Associate Director, Regulatory Information Management
    BeiGene, United States
  • Sandra  Krogulski, MA
    Sandra Krogulski, MA Associate Director, Submission Management
    Bristol-Myers Squibb Company, United States
  • Rob  Labriola, MS
    Rob Labriola, MS Exec. Director, Regulatory Operations
    Synchrogenix, United States
  • Daniel  Offringa
    Daniel Offringa Principal Consultant
    eSub Solutions, United States
  • Jonathan  Resnick, PMP
    Jonathan Resnick, PMP Project Management Officer, OBI, OSP, CDER
    FDA, United States
  • Representative Invited
    Representative Invited DIA, United States
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