Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations

This course provides an overview of Postmarketing Adverse Drug Experience (PADE) regulations, guidance, inspectional candidate selection, inspectional techniques, and regulatory actions to enhance the field investigator’s knowledge. Topics in this course include: Reporting, FAERS, Types of ADE Reports, ADE Team, Inspecting, and Compliance. After completing this course, learners will be able to recognize how to perform the inspectional activities necessary to monitor industry’s surveillance, receipt, evaluation, and submission of adverse drug experience information to FDA.

After this course learners will be able to identify the role of the postmarketing adverse drug experience reporting compliance program in monitoring and enforcing the drug safety reporting regulations. recognize when the pharmaceutical industry is complying with its adverse drug experience reporting responsibilities. recognize how to perform the inspectional activities necessary to monitor industry’s surveillance, receipt, evaluation, and submission of adverse drug experience information to fda. identify the regulations and guidance documents that are the foundation of the inspectional program.