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Bethesda North Marriott Hotel and Conference Center

Feb 14, 2022 8:30 AM - Feb 16, 2022 2:15 PM

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

Regulatory Submissions, Information, and Document Management Forum

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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

Short Course or Primer

To keep you at the forefront.

Feb 13, 2022

Regulatory Content and Submission Primer:

Content from Authoring to Archive

Feb 09, 2022

Short Course:

Structured Data

Feb 08, 2022

Short Course:

The Future of Documents

Program Committee

  • Venkatraman  Balasubramanian, PhD, MBA
    Venkatraman Balasubramanian, PhD, MBA SVP and Global Head, Industry Solutions - Healthcare and Life Sciences
    Orion Innovation, United States
  • Karen  McCarthy Schau
    Karen McCarthy Schau Director, Risk-based Study Management
    Vertex Pharmaceuticals, United States
  • Peter  Terbeek, MBA
    Peter Terbeek, MBA Senior Director, Regulatory Operations
    United States
  • Jake  Doran
    Jake Doran Head of Digital
    Lykos Therapeutics, United States
  • Jo  English
    Jo English Chief Strategy Officer
    Ennov, United Kingdom
  • Michiel  Stam
    Michiel Stam Director Regulatory Information Management
    Qdossier - A Celegence Company, United Kingdom
  • Danielle  Beaulieu, PhD
    Danielle Beaulieu, PhD Senior Director, Global Regulatory Business Capabilities
    Bristol-Myers Squibb, United States
  • Kristen  Sauter, MBA
    Kristen Sauter, MBA Senior Director, Head, Global RIM, Analytics & Digital Innovation
    Takeda Pharmaceuticals, United States
  • Vahe  Ghahraman, PhD
    Vahe Ghahraman, PhD Senior Director, Global Regulatory Operations Head
    Apellis Pharmaceuticals, Inc. , United States
  • Cindy  Chiu
    Cindy Chiu Senior Director, Regulatory Affairs Operations and Quality Management
    Merck & Co., Inc., United States
  • Joanne  Malia, MS, MSc
    Joanne Malia, MS, MSc Director, Development Records Management
    Regeneron Pharmaceuticals, United States
  • Jamie  O'Keefe
    Jamie O'Keefe Head, Clinical & Regulatory Consulting
    Astrix, United States
  • Stacy  Tegan
    Stacy Tegan Program Director
    Transcelerate Biopharma, Inc., United States
  • Divya  Gangaramani, PhD, RAC
    Divya Gangaramani, PhD, RAC Senior Regulatory Specialist
    VIR Biotech, United States
  • Rob  Labriola, MS
    Rob Labriola, MS Exec. Director, Regulatory Operations
    Garuda Therapeutics, United States
  • Sandra  Krogulski, MA
    Sandra Krogulski, MA Director, GRSO Innovation and Business Operations Lead
    Bristol-Myers Squibb Company, United States
  • Demetra  Macheras, MBA
    Demetra Macheras, MBA Director, Regulatory Policy and Intelligence - Regulatory Affairs
    AbbVie, 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
  • Jonathan  Resnick, PMP
    Jonathan Resnick, PMP Project Management Officer, OBI, OSP, CDER
    FDA, United States

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