Pharmacovigilance
Pharmacovigilance (PV)—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 historic events, as well as an increased understanding of the factors that affect drug safety. While there are differences in adverse event reporting obligations among agencies worldwide, recent initiatives have harmonized standards and practices within the industry. Despite these efforts at harmonization, there still remain many regional differences. This will continue to be a major challenge for pharmacovigilance departments as issues such as increased reporting requirements, risk management plans and regional guidances continue to evolve.
This introductory course provides an overview of pharmacovigilance across a spectrum of topics, presenting both US and global perspectives. You will learn the basic concepts, regulatory requirements, and recent trends and approaches, to understanding and communicating a safety profile..
At a Glance
- 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 EU.
- Learning Level: Basic
- Total Length of Course: 4 Hours
- RAC Points: 4
- Pharmaceutical Certificate Elective
- Enrollment Period: 12 months
Learning Objectives
Upon completion of this course, participants should be able to:- Discuss the theory and background of pharmacovigilance, as well as identify major terminology in this arena
- Explain methods used to identify safety signals and statistical effects
- Cite the differences between aggregate Periodic and Periodic Safety Update Reports
- Identify the unique challenges of pharmacovigilance in special patient populations such as pregnant women, the elderly and children
- Identify the common operational activities within drug safety departments
- Describe the drug safety reporting requirements
- Recognize the role of pharmacovigilance in drug warnings and recalls and drug labeling
- Outline the similarities, differences and varied interests of stakeholders in pharmacovigilance
Lesson Titles
- Lesson 1: Concepts and Definitions
- Lesson 2: Operational Activities
- Lesson 3: Safety Reporting and Surveillance around the World
- Lesson 4: Interests and Challenges in Pharmacovigilance
- Lesson 5: Special Populations
- Lesson 6: Periodic Report and PSUR
- Lesson 7: Coding
- Lesson 8: Signal Detection and Investigation
- Lesson 9: Product Issues, Warnings and Labeling
- Lesson 10: Electronic Reporting
This course is also included in:
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