Risk Evaluation and Mitigation Strategy (REMS) Assessments: Social Science Methodologies to Assess Goals Related to Knowledge: Public Workshop

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge.” The purpose of the public workshop is to initiate constructive dialogue and information-sharing among regulators, researchers, the pharmaceutical industry, health care organizations, health care providers, and others from the general public about survey methodologies and instruments that can be used to evaluate patients’ and health care providers’ knowledge about the risks of drugs marketed with an approved REMS.

The input from this workshop will be used to develop guidance for industry describing best practices for conducting an assessment of a REMS goal regarding patient and/or health care provider knowledge about a drug’s risk(s). To assist in the workshop discussion and the ultimate development of the guidance, FDA is making available an issue paper that discusses our experience with knowledge assessments for REMS and contains specific questions we hope to receive input on.

• Federal Register Notice
• Issue Paper (PDF - 96KB)
• Workshop Description (PDF - 15KB)
• Visitor Information
• Agenda (PDF - 21KB)
• Examples of questions on Prescriber Surveys conducted to assess knowledge as a part of a Risk Evaluation and Mitigation Strategy (PDF - 38KB)
• Slides from the Risk Evaluation and Mitigation Strategy Assessment Public Workshop
• Panel Members (PDF - 23KB)
• Open Public Session Speakers (PDF - 28KB)
• Transcript: Thursday, June 7, 2012 (PDF - 732KB)

Date and Time: Thursday, June 7, 2012 from 8:00 am - 5:00 pm

Location: FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31 Conference Center, The Great Room (Room 1503), Silver Spring, MD 20993-0002

Contact Person: Elaine Ferguson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg 22, Room 4462, Silver Spring, MD, 20993, 301-796-9012, FAX 301-796-9832, E-mail: elaine.ferguson@fda.hhs.gov

Information sent to the previous contact, Colleen O'Malley will be forwarded to Elaine Ferguson.

Registration and Requests for Oral Presentations Only: The registration deadline for oral presentations is May 21, 2012 and all must register by email at KnowledgeAssessmentWorkshop@fda.hhs.gov

The public is welcome to attend the workshop on a first come, first served basis.