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Bethesda North Marriott Hotel and Conference Center

Feb 12, 2024 8:00 AM - Feb 14, 2024 2:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!


February 6: Short Course

February 8: Short Course

February 8 and 12: Primer

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. New for 2024, our Forum brings a refreshed set of tracks and focus areas, equipping our attendees with invaluable insights on how to build and sustain successful RSIDM foundations, optimize their current processes and procedures, adopt innovative technologies, and achieve regulatory excellence. This Forum provides multiple opportunities for networking, knowledge sharing, and education for both business and technology-focused attendees at all levels.


27 educational sessions, 90+ diverse speakers from regulatory, industry and academia, 8 networking opportunities, 30+ exhibitors & sponors, 4 hosted case study spotlights, 2 pre-forum virtual Short Courses, 1 pre-forum hybrid Primer, and more!

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, CBER, 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.

Keynote Address!

February 12 | 1:25 - 2:00 PM

Keynote Address

Session 1: Keynote Address : Fostering Trustworthy and Responsible AI

The Keynote has Been Released! Reggie Townsend, MBA, Vice President, Data Ethics, SAS


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

Continuing Education


View our Exhibit Partners and explore our latest offerings

Highlights & Features

Stay in the know with what's going on at the event

Welcome Video

Who should attend?

  • 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
    • 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

Learning objectives

  • At the completion of this conference, the participant should be able to:

    • Develop insights into effective strategies for establishing and sustaining robust regulatory submission, information, and document management foundations
    • Explore techniques to enhance organizational processes and procedures, fostering a culture of innovation and forward-thinking
    • Gain thought-provoking insights on effectively adopting innovative technologies, such as artificial intelligence and automation, into your organization
    • Develop a comprehensive understanding of the elements required for achieving regulatory excellence in the life sciences industry
    • Discuss current global regulatory authority updates and key initiatives as it relates to data standards, analytics, electronic submissions, and IT programs

Short Course or Primer

To keep you at the forefront.

Feb 06, 2024

Short Course:

Driving IDMP Readiness and Compliance

Feb 08, 2024

Short Course:

Mapping Common Regulatory Data Standards to FHIR

Program Committee

  • Jo  English
    Jo English Chief Strategy Officer
    Ennov, 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
  • Rob  Labriola, MS
    Rob Labriola, MS Exec. Director, Regulatory Operations
    Garuda Therapeutics, United States
  • Jamie  O'Keefe
    Jamie O'Keefe Head, Clinical & Regulatory Consulting
    Astrix, United States
  • Alison  Buno, MBA
    Alison Buno, MBA Senior 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 Industry Expert
    Retired, 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
  • Jared  Lantzy, PMP
    Jared Lantzy, PMP Executive 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 Principal Product Manager
    Accumulus Synergy, United States
  • Daniel  Offringa
    Daniel Offringa Principal Consultant
    eSub Solutions, 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, MHA
    Maria Sagoua, MHA Director of Regulatory Innovation
    Accumulus Synergy, United States
  • Kristen  Sauter, MBA
    Kristen Sauter, MBA Senior Director, Head, Global RIM, Analytics & Digital Innovation
    Takeda Pharmaceuticals, United States
  • Matthias  Sijtstra
    Matthias Sijtstra Senior Data Management Specialist
    Celegence Netherlands, Netherlands
  • Cary  Smithson, MBA
    Cary Smithson, MBA Managing Partner
    Leapahead Solutions, Inc., United States
  • Representative Invited
    Representative Invited DIA, United States

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