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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Public Workshop: Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products

March 31, 2014
8:30 a.m - 4:30 p.m.

Workshop Goals and Objectives

The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), is announcing a public workshop entitled “Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products.” The purpose of the public workshop is to bring together a broad range of stakeholders to discuss current and future standards development activities involving cellular therapies and regenerative medicine products.

Standardization efforts concerning the clinical development of cellular therapies and regenerative medicine products have generated a great deal of interest. These efforts include standards development, expert opinion position papers, and professional practice guidelines. However, relatively little is done to coordinate the various existing efforts. In the public workshop, FDA hopes to bring together a broad range of stakeholders of cellular therapies and regenerative medicine products in order to:

  • Inform stakeholders about the types of standards and standards organizations that are available currently, the role that the Federal Agencies play in standards development, and the potential role that stakeholders can play in standards development.

  • Provide a high-level overview of current standards development activities in the fields of cellular therapy and regenerative medicine and the regulatory application of standards.

  • Provide opportunity for discussion of areas of high interest for current or future standards development in the fields of cellular therapy and regenerative medicine and to explore ways to minimize redundancy and maximize collaboration.

We encourage all who have an interest in the development of cellular therapies and regenerative medicine products to attend the public workshop.

Location

The public workshop will be held at the following location:

FDA White Oak Campus
The Great Room, Bldg. 31, Room 1503A
10903 New Hampshire Ave
Silver Spring, MD 20993

Please visit the following Website for location, parking, security, and travel information:
http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

The public workshop will also be available to be viewed online via webcast.
Streaming Webcast of the Public Workshop: For those unable to attend in person, FDA will Webcast the public workshop. To join the Webcast of the public workshop, please go to: https://collaboration.fda.gov/sesdctrmpworkshop/.

If you have never attended an Adobe Connect meeting before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. Get a quick overview: http://www.adobe.com/go/connectpro_overview.

Registration is not required for those attending via Adobe Connect.

Registration

Mail or fax your registration information (including name, title, firm name, address, telephone, and fax numbers) to Sherri Revell (see Contact Person) or email to CBERPublicEvents@fda.hhs.gov (Subject line: SESDCTRMP Workshop Registration) by March 24, 2014. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space available basis beginning at 7:30 a.m.

Contact Person

Sherri Revell
Office of Communication, Outreach, and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike, Suite 200N, HFM-49
Rockville, MD 20852-1448
Phone: 301-827-2000
Fax: 301-827-3079
e-mail: CBERPublicEvents@fda.hhs.gov (Subject Line: SESDCTRMP Workshop)