Office of Surveillance and Epidemiology (OSE) - Divisions

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The Office of Surveillance and Epidemiology consists of five divisions:

• Division of Risk Management
• Division of Medication Errors Prevention and Analysis
• Division of Epidemiology
• Division of Pharmacovigilance I
• Division of Pharmacovigilance II

Division of Pharmacovigilance I & II (DPVI & DPVII)

DPV I & DPV II staff include safety evaluators whose primary role is to detect and assess safety signals for all marketed drug products. They work closely with medical reviewers in the Office of New Drugs so that potential safety signals are placed in the context of existing preclinical, clinical, or pharmacologic knowledge of the drugs in question.

Division of Epidemiology (DEPI)

Our epidemiologists review epidemiologic study protocols that are increasingly required of manufacturers as post marketing commitments. They evaluate various postmarketing surveillance tools that may be incorporated into risk management strategies, such as patient registries and restricted distribution systems. They estimate the public health impact of safety signals by evaluating computerized databases and the published literature.

Division of Medication Error Prevention and Analysis (DMEPA)

DMEPA primarily provides pre-marketing reviews of all proprietary names, labels and labeling in CDER in order to reduce the medication error potential of a proposed product. DMEPA also provides post-marketing review and analysis of all medication errors CDER receives.

Division of Risk Management (DRISK)

DRISK handles data resources, risk communication, and outcomes and effectiveness research components of drug safety risk management programs (REMS). This Division oversees MedWatch, risk communication research and activities such as Medications Guides, Patient Packet Inserts, and pharmacy information surveys, and international regulatory liaison activities (such as videoconferencing) for all drug and biologic postmarketing safety issues.