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Bethesda North Marriott Hotel and Conference Center

Feb 10, 2020 11:00 AM - Feb 12, 2020 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 09, 2020

Regulatory Content and Submission Primer:

Content from Authoring to Archive

Feb 10, 2020

Short Course 1:

Data at the Heart of Life Science Professionals

Feb 10, 2020

Short Course 2:

Preparing and Submitting Standardized Study Data to FDA, Presented by FDA, CDER

Program Committee

  • Brooke  Casselberry, MS, RAC
    Brooke Casselberry, MS, RAC Vice President, Advisory and Delivery
    Epista Life Sciences, United States
  • Michelle L. Charles, MPH
    Michelle L. Charles, MPH Director, Regulatory Affairs, Gene Therapy Program
    University of Pennsylvania, Perelman School of Medicine, United States
  • Cindy  Chiu
    Cindy Chiu Senior Director, Regulatory Affairs Operations and Quality Management
    Merck & Co., Inc., United States
  • Ron  Fitzmartin, PhD, MBA
    Ron Fitzmartin, PhD, MBA Senior Advisor, Office of Regulatory Operations, CBER
    FDA, United States
  • Venkatraman  Balasubramanian, PhD, MBA
    Venkatraman Balasubramanian, PhD, MBA Healthcare and Life Sciences Strategic Advisor
    VB Insights, LLC, United States
  • Danielle  Beaulieu, PhD
    Danielle Beaulieu, PhD Senior Director, Global Regulatory Business Capabilities
    Bristol-Myers Squibb, 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
  • Jake  Doran
    Jake Doran Vice President, Digital
    Lykos Therapeutics, United States
  • Ginny  Hussong
    Ginny Hussong Branch Chief, Data Standards, CBER
    FDA, 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
  • Thomas  Noto
    Thomas Noto Senior Director, Regulatory Operations
    Lexicon Pharmaceuticals, United States
  • Daniel  Orfe, MS
    Daniel Orfe, MS President and CEO
    Regulatory eSubmissions, LLC, United States
  • Michiel  Stam
    Michiel Stam Management Consultant
    MAIN5 Gmbh & Co. Kgaa, Germany
  • Stacy  Tegan
    Stacy Tegan Program Director
    Transcelerate Biopharma, Inc., United States
  • Peter  Terbeek, MBA
    Peter Terbeek, MBA Senior Director, Regulatory Operations
    United States
  • Kevin  Tompkins, MBA
    Kevin Tompkins, MBA Executive Director, Regulatory Information & Submission Management
    Bristol Myers Squibb, United States

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