Zdrowie i gospodarka · 07/04/2011
Statement of Organizations, Functions, and Delegations of Authority
The Food and Drug Administration (FDA) has reorganized the Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE). This reorganization includes the organizations and their substructure components as listed in this document. This reorganization includes the establishment of six Staffs: Executive Operations and Strategic Planning Staff, Regulatory Science Staff, Regulatory Affairs Staff, Program Management and Analysis Staff, Project Management Staff, and Technical Information Staff. It will also include Office of Medication Error Prevention and Risk Management (OMEPRM) and Office of Pharmacovigilance and Epidemiology (OPE) under OSE. OMEPRM will consist of the Division of Risk Management and the Division of Medication Error Prevention and Analysis. OPE will consist of the Division of Epidemiology I and Division of Epidemiology II and the Division of Pharmacovigilance I and Division of Pharmacovigilance II. Also included are the abolishment of Business Process Improvement Staff, Regulatory Policy Staff, and Review Management Staff within OSE Immediate Office.