Pharmacovigilance—the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems—is a dynamic and rapidly changing area of the pharmaceutical industry. As a critical component of ensuring consumer safety, the role of pharmacovigilance has been shaped by several historical events, as well as an increased understanding of the factors that affect drug safety. While there are differences in adverse event reporting obligations between agencies worldwide, recent initiatives have harmonized standards and practices within the industry. This harmonization will continue to be a major challenge for pharmacovigilance departments, as issues such as electronic reporting, risk management plans and regionally based guidance continue to evolve.
This introductory course provides an overview of the basic elements at play in pharmacovigilance across a spectrum of topics, from both US and European perspectives. You will learn major industry concepts and recent trends and approaches to understanding and communicating a comprehensive and up-to-date drug safety profile.
Learning Objectives
Upon completion of this course, students should be able to:
- Discuss the theory and background of pharmacovigilance, as well as identify major terminology in this arena
- Explain common epidemiological tools used to identify safety signals and statistical effects
- Cite the differences between aggregate Periodic and PSUR reports, as well as the benefits and risks of electronic reporting
- Identify the unique challenges of pharmacovigilance in special populations such as pregnant women, the elderly and pediatric patients
- Identify the common operational activities within drug safety departments
- Describe the drug safety reporting requirements of regulatory agencies, regulatory surveillance, and standards for coding adverse events and concomitant medications
- Recognize the role of pharmacovigilance in product issues, drug warnings and recalls and drug labeling
- Outline the similarities, differences and varied interests of stakeholders in pharmacovilance
Target Audience
This course is intended for regulatory professionals or others in related areas who are interested in learning the basic concepts and principles of pharmacovigilance in the US and Europe.