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Virtual Event

2021 年 02 月 08 日 10:00 上午 - 2021 年 02 月 10 日 4:30 下午

(Eastern Standard Time)

Horsham, PA 19044

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.

2021 年 02 月 04 日

Regulatory Content and Submissions Primer:

Content from Authoring Through Archive

2021 年 02 月 05 日

Short Course 1:

Regulatory Considerations for Blockchain in Clinical Research and Drug Development

项目委员会

  • Brooke  Casselberry, MS, RAC
    Brooke Casselberry, MS, RAC Vice President, Advisory and Delivery
    Epista Life Science, United States
  • Cindy  Chiu
    Cindy Chiu Senior Director, Regulatory Affairs Operations
    Merck & Co., Inc., United States
  • Peter  Terbeek, MBA
    Peter Terbeek, MBA Executive Director, Regulatory Data and Document Operations
    Astellas Pharmaceuticals, United States
  • Ron  Fitzmartin, PHD, MBA
    Ron Fitzmartin, PHD, MBA Principal Consultant
    Decision Analytics, United States
  • Thomas  Noto
    Thomas Noto Senior Director, Regulatory Operations
    Lexicon Pharmaceuticals, United States
  • Venkatraman  Balasubramanian, PHD, MBA
    Venkatraman Balasubramanian, PHD, MBA Healthcare and Life Sciences Strategic Advisor
    VB Insights, LLC, United States
  • Jo  English
    Jo English
    IRISS Forum, United Kingdom
  • Jake  Doran
    Jake Doran Managing Director
    List Innovations, United States
  • Michiel  Stam
    Michiel Stam Management Consultant
    MAIN5 Gmbh & Co. Kgaa, Germany
  • 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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