World OF DRUG SAFETY MODULE

Learning Objectives

Upon completion of the Overview of Drug Safety unit, you will be able to:

• Describe the roles and responsibilities of CDER's Office of Surveillance and Epidemiology (OSE).
• Discuss the types of Risk Evaluation and Mitigation Strategies (REMS).
• Explain adverse event reports and usage data.
• Describe naming errors.
• Discuss the tools for risk assessment and evaluation.
• Discuss the history of unapproved drugs.
• Explain the Adverse Event Reporting System (AERS).
• Discuss data mining and how it is used within the OSE.
• Explain how the epidemiology databases are used.
• Discuss the Sentinel Initiative's impact on drug safety.
• Explain the Drug Safety and Risk Management Advisory Committee's importance within FDA.
• Discuss FDA's safety and global initiatives and their importance within the organization.

Now that you understand the objectives we are trying to achieve, let's begin this unit.