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Mission Statement: The North America Legal and Regulatory Affairs Committee of the ISCT serves the membership and others working in Cellular Therapy by providing information regarding U.S., Canadian and International Regulations, Standards, Guidance documents and published best practices and by presenting the regulatory concenrs of teh membership back to Regulatory Agencies.
The committee will:
· Inform members of potential and actual changes in regulations,
· Notify members of published draft and final guidance documents,
· Provide information to members to assist with compliance with US, Canadian, and Internatiional Standards,
· Collate and forward comments to Regulatory Agencies concerning regulatory issues,
· Recommend revision of standards to accrediting agencies,
· Communicate regulatory concerns to other ISCT committees and the Board of Directors.
Regulatory Affairs North America Resources
Chair:
Kurt Gunter, MD
Lake Forest, IL
kurt.gunter@hospira.com
Committee Members:
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Wade Atkins
Bethesda, MD
Shirley Bartido
New York, NY
Nancy Collins
New York, NY
Karen Edward
Seattle, WA
Willis Ennis
Walkersville, MD
Joseph Fratantoni
Gaithersburg, MD
John Gilbert
Boston, MA
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Liana Harvath
Bethesda, MD
Cheryl Hastings
Lakewood, CO
Asiya Imam
San Jose, CA
William Janssen
Tampa, FL
Grace Kao
Boston, MA
Victoria Lake
Seattle, WA
Karen Nichols
Cambridge, MA
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Denise Oppermann
Exton, PA
Fran Rabe
Minneapolis, MN
Andrew Walton
Orange, CA
Jesse Seidman
McGaw Park, IL
Jim Williams
The Woodlands, TX
Joyce Frey
Washington, DC
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Recent Activities:
Input into annual meeting content.
Abstract review and scoring.
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