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Virtual Event

2021年2月08日 (月) 午前 10:00 - 2021年2月10日 (水) 午後 4:30

(Eastern Standard Time)

Horsham, PA 19044

Regulatory Submissions, Information, and Document Management Forum

Featured

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2月04日 (木)

Regulatory Content and Submissions Primer:

Content from Authoring Through Archive

2021年2月05日 (金)

Short Course 1:

Regulatory Considerations for Blockchain in Clinical Research and Drug Development

プログラム委員会

  • Brooke  Casselberry, MS, RAC
    Brooke Casselberry, MS, RAC Vice President, Advisory and Delivery
    Epista Life Sciences, 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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