Safe Use Initiative; Public Workshop
The 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 November 10, 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 5:00 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)
- Agenda (PDF - 63KB)
- Transcript: Tuesday, November 16, 2010 (PDF - 4MB)
- Transcript: Wednesday, November 17, 2010 (PDF - 2MB)
Virginia A. Cox, ESQ., Senior Vice President, Communications & Strategic Initiatives, Consumer Healthcare Products Association (CHPA)(PDF - 794KB) [ARCHIVED] Wm. Ray Bullman, Executive Vice President, National Council on Patient Information and Education (NCPIE)(PDF - 92KB) [ARCHIVED] Edwin Kuffner, M.D., Medical Affairs, McNeil Consumer Healthcare(PDF - 281KB) [ARCHIVED] Joseph Pergolizzi, M.D., Johns Hopkins University(PDF - 1.3MB) [ARCHIVED] Dan Budnitz, M.D., M.P.H., Director, Medication Safety Program, Centers for Disease Control and Prevention(PDF - 772KB) [ARCHIVED] Barbara Kochanowski, Ph.D., Vice President Regulatory Affairs, Consumer Healthcare Products Association (CHPA)(PDF - 427KB) [ARCHIVED] John Eadie, Center Director, Prescription Drug Monitoring Program Center of Excellence (PMP COE), Brandeis University Heller School for Social Policy and Management(PDF - 2MB) [ARCHIVED] Sean Clarkin, Executive Vice President, Director of Strategy and Programs, The Partnership at DrugFree.org(PDF - 120KB) [ARCHIVED] Sara Weir, Vice President, B&D Consulting(PDF - 1.3MB) [ARCHIVED] Gina Pugliese, RN MS, Premier Healthcare Alliance(PDF - 270KB) [ARCHIVED] Chip Amoe, J.D., M.P.A, American Society of Anesthesiologists(PDF - 125KB) [ARCHIVED] Joseph Perz, DrPH, Centers for Disease Control and Prevention(PDF - 628KB) [ARCHIVED]
- Joanne Locke, Center for Plain Language (PDF - 103KB) [ARCHIVED]