Overview
This is a basic- to intermediate-level overview course, intended for individuals who have at least some experience in clinical safety of biopharmaceutical products. The focus will be on pharmacovigilance of traditional medicinal products intended for human use. Topics will span investigational and marketed products as used in clinical trials, in post-marketing studies, and under conditions of actual use in real-world healthcare settings.
What You Will Learn
- Legal basis for safety reporting including a historical perspective
- Basic definitions and tools
- Evaluation of seriousness, expectedness, and causality
- Safety reporting requirements in the pre-marketing phase
- Data collection, processing, and requirements in the post-marketing phase
- Case studies and practical exercises
- Active safety surveillance in the post-marketing phase
- Audits and inspections
- Introduction to signal detection and risk assessment
- Basics of risk management in the US and EU
- Principles of pharmacoepidemiology
Who Should Attend
Individuals with limited to intermediate experience in the area of clinical safety or pharmacovigilance, including those from the pharmaceutical industry, academia, and drug regulatory authorities, should attend. In addition, those with job roles in medical writing, marketing, and those who need an overview of clinical safety and may interact with members of those departments, should attend.
Learning Objectives
Participants who complete this training should be able to:
- Identify the history, principles, and regulatory framework for clinical drug safety
- Discuss the basic definitions of terms used in day-to-day pharmacovigilance work
- Recognize basic international regulatory requirements for safety surveillance, as well as those requirements specific for the US and EU
- Describe the criteria and elements of expedited and periodic reporting of drug safety from first in human studies through the post-marketing phase
- Demonstrate an awareness of risk management principles and pharmacoepidemiology