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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

Regulatory Submissions, Information, and Document Management Forum

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

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

Continuing Education

Highlights & Features

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Welcome Video

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
    IRISS Forum, United Kingdom
  • Sandra  Krogulski, MA
    Sandra Krogulski, MA Director, GRSO Innovation and Business Operations Lead
    Bristol Myers Squibb, United States
  • Ethan  Chen, MBA, MS, PMP
    Ethan Chen, MBA, MS, PMP Director, Division of Data Management
    FDA CDER, 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., 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 & Regulatory Consulting Lead
    Main5 GmbH & Co. KGaA, Germany
  • Jared  Lantzy, PMP
    Jared Lantzy, PMP Executive Director, Global Regulatory Operations
    Novavax, 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 Director
    Epista Life Science, United States
  • Daniel  Offringa
    Daniel Offringa Principal Consultant
    eSub Solutions, United States
  • Neel  Patel, MS
    Neel Patel, MS Director of Technology
    Epista Life Science, United States
  • Nimesh  Patel
    Nimesh Patel Director of Global Regulatory Systems
    Eisai Co., Ltd., United States
  • Jonathan  Resnick, PMP
    Jonathan Resnick, PMP Project Management Officer, OBI, OSP, CDER
    FDA, United States
  • Maria  Sagoua, MHA
    Maria Sagoua, MHA
    United States
  • Kristen  Sauter, MBA
    Kristen Sauter, MBA Life Science Consulting, Regulatory AI and Data Practice
    Deloitte, United States
  • Matthias  Sijtstra
    Matthias Sijtstra Senior Consultant
    Main5 GmbH & Co. KGaA, Netherlands
  • Cary  Smithson, MBA
    Cary Smithson, MBA Managing Partner
    LeapAhead Solutions, Inc., United States
  • Representative Invited
    Representative Invited DIA, Switzerland

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