Public Workshop: FDA Regulation and Licensure of Whole Blood and Blood Components
September 15, 2009 8:00 a.m. – 5:30 p.m.
September 16, 2009 8:00 a.m. – 4:00 p.m.
Workshop Goals and Objectives The Food and Drug Administration (FDA) is announcing a public workshop entitled: FDA Regulation and Licensure of Whole Blood and Blood Components, including Source Plasma. The purpose of the workshop is to educate industry on the licensure requirements and license application procedures for Whole Blood and blood components, including Source Plasma.
FDA held a licensing workshop for blood establishments in 1995 to advise the blood and plasma industry on how to apply for a U.S. license to distribute Whole Blood and blood components, including Source Plasma, in interstate commerce. This workshop will build upon the 1995 workshop and provide regulatory updates since the last workshop. The workshop will include presentations by FDA on the following topics: (1) requirements for licensure, and applicable regulations and guidance documents for Whole Blood and blood components, including Source Plasma; (2) managed review process; (3) review criteria for various submissions; (4) blood establishment registration and product listing requirements; (5) inspections of blood establishments pending licensure and approval; and (6) requests for exceptions or use of alternative procedures to the regulations. The workshop will include general sessions as well as break-out sessions with a particular focus on Whole Blood and blood components or Source Plasma. A question and answer session with workshop participants will also be included in the workshop.
Comments All individuals wishing to submit questions to be addressed at the public workshop should submit written or electronic comments by August 17, 2009, to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov
Location The Universities at Shady Grove Conference Center 9630 Gudelsky Drive, Bldg II, Multipurpose Room Rockville, MD 20850 http://www.shadygrove.umd.edu/about/directions/
Registration There is no registration fee for the workshop. Early registration is recommended before August 17, 2009, as seating is limited. Registration on the day of the workshop will be provided on a space available basis beginning at 7:30 a.m. To register, complete the attached registration form in this announcement and mail, fax or e-mail it to Rhonda Dawson, Food and Drug Administration, HFM-302, 1401 Rockville Pike, Rockville, MD 20852; Fax: 301-827-2843; E-mail: email@example.com Registrants will receive an e-mail confirmation.
If you need special accommodations due to a disability, please contact Rhonda Dawson at least seven days in advance of the workshop.
Overnight Accommodations Participants requiring overnight accommodations can contact one of the following hotels. These hotels offer reduced rates and shuttle bus service to the Universities at Shady Grove Conference Center and the Shady Grove Metro Station.
Crowne Plaza 3 Research Court Rockville, MD 20850 (301) 840-0200 http://www.cprockville.com Woodfin Suites Hotel 1380 Piccard Drive Rockville, MD 20850 (301) 590-9880 Comfort Inn Shady Grove 16216 Frederick Road Gaithersburg, MD 20877 (301) 330-0023 http://www.comfortinnshadygrove.com Residence Inn by Marriott 9721 Washington Blvd. Gaithersburg, MD 20878 (301) 590-3003 http://www.residenceinngaithersburg.com Holiday Inn Gaithersburg 2 Montgomery Village Avenue Gaithersburg, MD 20879 (301) 948-8900
For Program Information Contact Rhonda Dawson Program Coordinator Food and Drug Administration Office of Blood Research & Review Center for Biologics Evaluation and Research 1401 Rockville Pike, HFM-302 Rockville, MD 20852 Phone: 301-827-6129 Fax: 301-827-2843 e-mail: firstname.lastname@example.org
ver historia personal en: www.cerasale.com.ar [dado de baja por la Cancillería Argentina por temas políticos, propio de la censura que rige en nuestro medio]//
weblog.maimonides.edu/farmacia/archives/UM_Informe_Autoevaluacion_FyB.pdf - //
weblog.maimonides.edu/farmacia/archives/0216_Admin_FarmEcon.pdf - //
www.proz.com/kudoz/english_to_spanish/art_literary/523942-key_factors.html - 65k - // www.llave.connmed.com.ar/portalnoticias_vernoticia.php?codigonoticia=17715 // www.frusculleda.com.ar/homepage/espanol/activities_teaching.htm // http://www.on24.com.ar/nota.aspx?idNot=36331 ||