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February 12-14: 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. This Forum provides multiple opportunities for networking, knowledge sharing, and education for both business and technology-focused attendees.

While we develop our 2024 Agenda, please take a moment to review our 2023 FINAL PROGRAM!

Participant Testimonials

“The forum was incredibly valuable in terms of meeting colleagues from around the world —industry and regulators — and collaborating on solutions to improve submission efficiency andmake data more readily usable.”
Virginia Hussong, Chief Data Standards Program, CBDER, FDA

“Fantastic forum! I am 17 years in the pharmaceutical industry, but new to the regulatory sector, and it was great to align my prior manufacturing knowledge to the regulatory area. Great event! All the right people, all in the right place!”
Matthew Tyler, Director of Business Development, Qdossier, a Celegence Company

“The breadth of subject matter expertise, and diverse perspectives make RSIDM a must attend event for anyone involved in Regulatory activities.”
Gary Colantonio, MS, MBA, Associate Director, Regulatory Affairs, Merck & Co., Inc.


Want to learn more about Regulatory Submissions, Information, and Document Management Forum? You've come to the right site!
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Who should attend?

  • Meeting Designed For

    Join professionals from every corner of the vast realm of real-world data and real-world evidence:

    • 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
    • Clinical Data/Data Managers
    • Information Technology and Support Personnel
    • 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

Program Committee

  • Jo  English
    Jo English Vice President, Regulatory Information Management
    Calyx, United Kingdom
  • Sandra  Krogulski, MA
    Sandra Krogulski, MA Director, GRSO Innovation and Business Operations Lead
    Bristol-Myers Squibb Company, 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
  • Alison  Buno, MBA
    Alison Buno, MBA Sr. Director, Regulatory Submissions
    Abbvie, Inc., United States
  • Jillian E. Carinci, MS
    Jillian E. Carinci, MS Senior Director, Head of Submission Sciences
    Biogen, United States
  • Cindy  Chiu
    Cindy Chiu Senior Director, Regulatory Affairs Operations and Quality Management
    Merck & Co., Inc., United States
  • Joel  Finkle
    Joel Finkle Associate Director, Regulatory Information Management
    BeiGene, United States
  • Vahe  Ghahraman, PhD
    Vahe Ghahraman, PhD Senior Director, Global Regulatory Operations Head
    Apellis Pharmaceuticals, Inc. , United States
  • Dominik  Gigli
    Dominik Gigli Management Consultant
    Main5 GmbH & Co. KGaA, Germany
  • Rob  Labriola, MS
    Rob Labriola, MS Exec. Director, Regulatory Operations
    Garuda Therapeutics, United States
  • Jared  Lantzy
    Jared Lantzy Sr. Director, Global Regulatory Operations
    Novavax, Inc., United States
  • Teresa  Martins
    Teresa Martins Senior Director, US Site Head Regulatory Submission Management
    Bayer U.S. LLC, United States
  • Katherine  Novak, MS
    Katherine Novak, MS Senior Advisory Consultant, Life Sciences
    NNIT, United States
  • Daniel  Offringa
    Daniel Offringa Principal Consultant
    eSub Solutions, United States
  • Jamie  O'Keefe
    Jamie O'Keefe Head, Clinical and Regulatory Services
    Astrix Technology, Inc, United States
  • Neel  Patel, MS
    Neel Patel, MS Principal Consultant
    Red Nucleus, United States
  • Nimesh  Patel
    Nimesh Patel Director of Global Regulatory Systems & Operations
    Eisai Pharmaceuticals, United States
  • Jonathan  Resnick, PMP
    Jonathan Resnick, PMP Project Management Officer, OBI, OSP, CDER
    FDA, United States
  • Maria  Sagoua
    Maria Sagoua Director of Regulatory Innovation
    Accumulus Synergy, United States
  • Kristen  Sauter, MBA
    Kristen Sauter, MBA Director, Global Regulatory Informatics & Analytics
    Takeda Pharmaceuticals, United States
  • Matthias  Sijtstra
    Matthias Sijtstra Senior Regulatory Data Specialist
    Qdossier, A Celegence Company, Canada
  • Cary  Smithson, MBA
    Cary Smithson, MBA Senior Director, Regulatory; R&D Digital Transformation
    Pharmalex, United States
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