> To all, > > As you have expressed an interest in attending this one day public meeting > and workshop (to be held April 20th on the NIH campus), > here is further information. We will be providing lunch, so please RSVP > to let me know if you are coming. Please feel free to send this to any > other interested parties. An agenda for the meeting will follow later > this week. > > Public Meeting and Workshop Announcement > April 20, 2001 > > The Food and Drug Administration (FDA), Center for Biologics Evaluation > and Research (CBER), is announcing a public meeting and workshop entitled > "Safety Issues Pertaining to the Clinical Application of Flow Cytometry to > Human-Derived Cells." The purpose of the public meeting and workshop, > co-sponsored by the International Society for Analytical Cytology (ISAC), > is to discuss the scientific and technological issues related to > developing voluntary safety protocols for clinical flow cytometric > sorting of human-derived cells. The voluntary protocols will be used to > help ensure the safety of using flow cytometry to sort cells intended > for use in humans. The workshop will be of primary interest to public > health professionals developing clinical protocols that use flow cytometry > to sort cells for re-administration to humans, and to manufacturers of > these instruments. The objectives of the workshop are to define the safety > issues related to using flow cytometry to sort populations of human cells > intended for clinical use and to establish a working group to formulate > voluntary protocols to be used by investigators intending to use flow > cytometry in a clinical application. The following will be specifically > address (1) The protection of the operator of the flow cytometer to > potential human pathogens (2) the protection of the cellular product from > contamination; (3) the cleaning and sterilization of the flow cytometer > while ensuring a viable cellular product and (4) other issues related to > the development and adoption of these voluntary protocols. > Date and Time: The Safety Issues Pertaining to the Clinical Application of > Flow Cytometry to Human-Derived Cells public workshop will be held on > April 20, 2001 from 9:00 AM to 5:00 PM. > Location: The "Safety Issues Pertaining to the Use of Flow Cytometry to > Sort Human-Derived Cells for Clinical Applications" meeting will be held > in Building 29, Conference Room 129 (9:00 AM to 12:30 PM) and Building 29B > Conference Rooms A & B (12:30 PM to 5:00 PM), National Institutes of > Health, Bldg. 1, 8600 Rockville Pike, Bethesda, MD 20894. > Contact: Michele Keane-Moore, Center for Biologics Evaluation and Research > (HFM-594), Food and Drug Administration, 1401 Rockville Pike, Woodmont > Office Complex I, Suite 380N, Rockville, MD 20852, 301-827-5102, FAX > 301-827-5395, or e-mail: Mail to: keane-moore@cber.fda.gov. > Registration: Send or fax your registration information (including name, > title, organization name, address, telephone, fax number, and e-mail > address) to Michele Keane-Moore (address above) by Friday, March 30, 2001. > There is no registration fee for the meeting or workshop. Seating is > limited, therefore, interested parties are encouraged to register early. > Registration at the site will be done on a space available basis on the > day of the meetings, beginning at 8:30 a.m. > If you need special accommodations due to a disability, please contact > Michele Keane-Moore at least 7 days in advance. >
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