Course Description
Integration of foundational knowledge of clinical drug safety and pharmacovigilance requirements, combined with real-world application of these concepts. Emphasis on practical interpretation and application of relevant regulations and methods for optimizing the use of evolving technologies.
Athena Title
Drug Safety Pharmacovigilance
Non-Traditional Format
This course will be taught 95% or more online.
Prerequisite
Permission of department
Grading System
A - F (Traditional)
Course Objectives
- Outline the role of drug safety in the product development process from clinical to post-approval phases - Recognize good laboratory and clinical practices in the healthcare products industry - Understand the impact of drug safety in the process for new product applications - Describe the impact of clinical safety data on pre-approval and approval process for new and existing products - Compare key elements of drug safety and pharmacovigilance within the pharmaceutical, biotechnology, and bio-device industries - Locate information necessary in their role as regulatory affairs professionals - Distinguish between the subjective and interpretive aspects of the regulations - Understand the surveillance of products going from pre- to post-approval - Discuss the regulatory, market, environmental and other factors in post-approval product surveillance - General understanding of the role in signal detection and signal management in the pre-and post-approval phases
Topical Outline
Drug Development Process GLP Regulations Pre-clinical Safety Studies (pharmacology and toxicology focus, including PK profile) OECD and ICH Safety Guidelines IND Applications, Material Safety Data Sheet, and Investigator Brochure Clinical Trial Drug Safety Key Points, Safety Considerations for Biologics, Devices and Combination Products NDA Application Product Labeling Clinical Hold, Recall, and Product Withdrawals Post-approval Adverse Event Reporting Signal Trending and Detection Approaches Signal Management Environmental Risk Assessments Information Technology in Pharmacovigilance
Syllabus
Public CV