University City (PA)

SOCRA University City Chapter

 

Date: Tuesday, February 22nd, 2022 (02/22/2022)

Time (from – to): 10am-11am

Location and Address: Zoom*
   Please note: A Zoom link will only be sent to those individuals that RSVP; attendance is limited

Name of speaker: Dr. Wendy Charles, PhD, CIP, CCRP, CBP
Speaker title: Chief Scientific Officer for BurstIQ
Speaker affiliation (company or institution): Health Administration program, University of Colorado Denver.

Title of the program (or presentations): Novel Regulatory Challenges and Considerations for Blockchain in Health and Life Sciences Research

Overview:
The US Food and Drug Administration has included blockchain as a critical new technology in its Technology Modernization Action Plan and is testing blockchain effectiveness in pilot programs for the FDA’s Information Exchange and Drug Transformation (INFORMED) and Drug Supply Chain Security Act. Dr. Charles will provide a brief demonstration of an actual blockchain platform and discuss blockchain applications currently used for life sciences research and drug discovery. Dr. Charles will also discuss blockchain regulatory compliance and blockchain-based protections of electronic records and data.

Objectives:

  • Describe what blockchain is, how it operates from a non-technical perspective, and how it is currently being used in life sciences research;
  • Describe current uses of blockchain by the U.S. Federal government and life sciences organizations; and
  • Identify the framework of human research protections and privacy regulations that could apply to a blockchain research implementation.

Credits Available: 1 CE credit for SOCRA members (SOCRA members receive a certificate of attendance)

Questions:
Valerie Hess; Valerie.Hess@jefferson.edu
Project Manager, Training & Education
Jefferson Clinical Research Institute, Thomas Jefferson University
RSVP:
Valerie Hess; Valerie.Hess@jefferson.edu
Project Manager, Training & Education
Jefferson Clinical Research Institute, Thomas Jefferson University

 

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