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Virtual

Feb 08, 2021 10:00 AM - Feb 10, 2021 4:30 PM

(Eastern Standard Time)

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 04, 2021

Regulatory Content and Submissions Primer:

Content from Authoring Through Archive

Feb 05, 2021

Short Course 1:

Regulatory Considerations for Blockchain in Clinical Research and Drug Development

Program Committee

  • Brooke  Casselberry, MS, RAC
    Brooke Casselberry, MS, RAC Vice President, Engagement and Growth
    Accumulus Synergy, United States
  • Cindy  Chiu
    Cindy Chiu Senior Director, Regulatory Affairs Operations and Quality Management
    Merck & Co., Inc., United States
  • Peter  Terbeek, MBA
    Peter Terbeek, MBA Senior Director, Regulatory Operations
    United States
  • Ron  Fitzmartin, PhD, MBA
    Ron Fitzmartin, PhD, MBA Senior Informatics Advisor, Office of Regulatory Operations, CBER
    FDA, United States
  • Thomas  Noto
    Thomas Noto Senior Director, Regulatory Operations
    Lexicon Pharmaceuticals, United States
  • Venkatraman  Balasubramanian, PhD, MBA
    Venkatraman Balasubramanian, PhD, MBA SVP and Global Head, Industry Solutions - Healthcare and Life Sciences
    Orion Innovation, United States
  • Jo  English
    Jo English VP and General Manager, Enterprise Technology
    Calyx, United Kingdom
  • Jake  Doran
    Jake Doran Head of Digital
    Lykos Therapeutics, United States
  • 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
  • Joanne  Malia, MS, MSc
    Joanne Malia, MS, MSc Director, Development Records Management
    Regeneron Pharmaceuticals, United States
  • Karen  McCarthy Schau
    Karen McCarthy Schau Director, Risk-based Study Management
    Vertex Pharmaceuticals, United States
  • Daniel  Orfe, MS
    Daniel Orfe, MS President and CEO
    Regulatory eSubmissions, LLC, United States
  • Stacy  Tegan
    Stacy Tegan Program Director
    Transcelerate Biopharma, Inc., United States
  • Kevin  Tompkins, MBA
    Kevin Tompkins, MBA Executive Director, Regulatory Information & Submission Management
    Bristol Myers Squibb, United States
  • Jonathan  Resnick, PMP
    Jonathan Resnick, PMP Project Management Officer, OBI, OSP, CDER
    FDA, United States
  • Ginny  Hussong
    Ginny Hussong Branch Chief, Data Standards, CBER
    FDA, United States

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