Zdrowie i gospodarka · 21.08.2012
Post-Approval Studies 2012 Workshop: Design, Methodology, and Role in Evidence Appraisal Throughout the Total Product Life Cycle; Public Workshop; Request for Comments
The Food and Drug Administration (FDA) is announcing the following public workshop entitled "Post-Approval Studies 2012 Workshop: Design, Methodology, and Role in Evidence Appraisal Throughout the Total Product Life Cycle." The topics of discussion will include lessons learned from previous experiences with post- approval studies, improvement of implementation strategies for post- approval studies, best practices, and innovative methodologies for evidence appraisal. Date and Time: The public workshop will be held on August 30, 2012, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ ucm241740.htm. Contact Persons: Nilsa Loyo-Berrios, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66,