WIRB-Copernicus Group Biosafety Experts to Lead Human Gene Transfer Workshop at Annual American Biological Safety Conference
Session will provide an overview of industry challenges, risk assessment development, and the regulatory environment for human gene transfer research
PRINCETON, N.J., Oct. 9, 2015 – WIRB-Copernicus Group® (WCG™), the world’s largest provider of regulatory and ethical review services and software to support clinical research, announced today that two experts from its WCG Biosafety™ division will be leading a human gene transfer biosafety course at the American Biological Safety Association’s 58th Annual Conference in Providence, Rhode Island from Oct. 9-14.
“Human gene transfer research is starting to deliver medical breakthroughs using biological materials in targeted clinical applications,” said WCG Senior Vice President of Biosafety and Gene Therapy Christopher Jenkins, PhD, MPH, RBP. “This is an exciting but complex field and we want to help ensure that biosafety professionals and Institutional Biosafety Committees (IBCs) have the requisite knowledge to safeguard trial participants, their families, and research staff.”
Dr. Jenkins will be co-presenting the course entitled: “Biosafety Considerations with Human Gene Transfer” with WCG Director of IBC Services David Emery, PhD, from 1-5pm ET on Friday, Oct. 9.
Drs. Jenkins and Emery will provide an overview of the past and present challenges associated with gene transfer research in human subjects. They will also discuss risk assessment considerations for biosafety professionals and IBCs, and demonstrate how to generate risk assessments for biological materials used in clinical environments. In addition, they will review the pertinent Food and Drug Administration and National Institutes of Health regulations. Case studies and group discussion will be used to emphasize key points.
WCG Biosafety experts will also be available to discuss industry trends and answer important biosafety questions at booth #502.
For further information about this conference, please visit http://absaconference.org.
About WIRB-Copernicus Group
WIRB-Copernicus Group (WCG) is the world’s largest provider of regulatory and ethical solutions for clinical research. The company provides Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) reviews, and Human Research Protection (HRP), Good Clinical Practice (GCP) and Biosafety consulting services. Its technology offerings include IRB workflow management solutions (IRBNet), clinical trial management software for sponsors and contract research organizations (ePharmaSolutions), and Part-11 compliant online learning solutions for research professionals (WCG Academy).
The pioneer of independent ethical oversight, WCG continues to drive progress in the clinical research space. WCG empowers clients to accelerate life-saving advancements, while ensuring that the risks of progress never outweigh the value of human life.
For more information, please visit www.wcgclinical.com or follow us on Twitter @WCGClinical.
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