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Department of Health Informatics

Clinical Research Management

BPHE5725 - Adverse Event Reporting & Postmarketing Activities

Course Description

This course provides a comprehensive introduction to drug safety and pharmacovigilance. Regulations governing reporting of adverse events in clinical trials and postmarketing surveillance for drugs, biologics and medical devices required by the FDA and other global health authorities will be reviewed. Students will learn the basics of pharmacovigilance and how to conduct safety monitoring throughout the lifecycle of medical products. Risk management and safety evaluation will also be covered.

Credits/Modes of Instruction

Credits: 3

This course is a 3-credit, online graduate course provided via the Moodle Platform. The course is taught using a web-based format (directed study) with: Assigned readings, Links to relevant sites on the internet; Narrated PowerPoint slideshows (streaming audio or MP3 files); Directed discussion activities; Written assignments; Exams; session assignments, PDF formatted handouts, web-conference sessions, video links, podcasts, hyperlinks, readings and other information will be available at the course website or through the Rutgers Library Resources website.

Prerequisites

None

Course Goals and Outcomes:

Goals

The goal of this course is to provide an in-depth foundation of pharmacovigilance -- the science behind, and the activities involved with, the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. Additionally, the course will provide an overview of the regulatory requirements governing adverse events reporting.

Outcomes

Understand the history and evolution of pharmacovigilance; Define key medical product safety terms; Understand Good Pharmacovigilance Practices and the regulations relating to medical product safety; Describe the overall process to evaluate, monitor and report the safety of drugs, devices and biologics in clinical development as well as post-marketing; Understand the assessment of individual case safety reports including reference safety information.