Safe Use Initiative; Public WorkshopThe Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is announcing a public workshop entitled “Safe Use Initiative.” This one-and-one-half-day public workshop, organized and hosted by FDA’s Safe Use Initiative Team, will communicate the status of ongoing activities and future vision for Safe Use Initiative projects. The workshop will also offer an opportunity for the Safe Use Initiative Team to gather input and perspectives for future directions and develop collaborative, cross-sector safe medication use activities with healthcare stakeholders. It will provide a forum to engage the healthcare community about collaborations, interventions, and metrics for ongoing and future projects to make medications safer.
We are soliciting in advance of the public workshop topics for potential Safe Use collaborations. FDA will consider all topics; however, if submitted by October 15, 2010, some topics may become the focus for more in-depth discussions and partnership development during the public workshop. When submitting a topic for consideration, please suggest how it could become a Safe Use project, e.g., other healthcare partners who might have an interest in the issue, kinds of interventions to reduce preventable harm, metrics, etc. Submit electronic comments to
http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Maryland 20852.
Date(s): November 16-17, 2010
Time: November 16, 2010, from 8:30 a.m. to 4:45 p.m., EST.
November 17, 2010, from 8:30 a.m. to 12:00 p.m., EST.
Location: FDA White Oak Complex
10903 New Hampshire Avenue
Bldg. 31, Room 1503
Silver Spring, Maryland 20993–0002
Federal Register Notice (PDF - 56KB)Visitor Information
All meeting attendees must enter through Building 1 on the FDA White Oak Campus. Parking is available in the Southeast surface lot and a shuttle bus will be available to bring attendees from the lot to Building 1. Please see Map of White Oak Visitor Parking (PDF - 105KB) for directions.
RegistrationThere is no fee to attend the workshop, and attendees who do not wish to make an oral presentation do not need to register. Seating is limited and will be on a first-come, first-served basis.
If you would like to make an oral presentation during the public session (on November 17, 2010), you must register. Please submit your name, title, business or organization affiliation (if applicable) address, telephone number, fax number and e-mail address and provide an abstract of your presentation by close of business October 15, 2010 to the contact person.
If you need special accommodations because of a disability, please contact Sharon Bakayoko, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 51, Room 1353, Silver Spring, Maryland 20993-0002, phone (301)796-7600, e-mail
CDERSafeUseInitia@fda.hhs.gov at least 7 days before the workshop.
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