| Course ID: | PHAR 6140E. 4 hours. |
| Course Title: | Overview of Drug Safety Throughout Medical Product Lifecycle |
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. |
| Oasis Title: | Drug Safety Pharmacovigilance |
| Nontraditional Format: | This course will be taught 95% or more online. |
| Prerequisite: | Permission of department |
| Grading System: | A-F (Traditional) |
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| 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 |
| Honor Code Reference: | All academic work must meet the standards contained in A Culture of Honesty. Each student is responsible to inform themselves about those standards before performing any academic work. A Culture of Honesty is the University of Georgia's policy and procedures for handling cases of suspected dishonesty and can be found online at www.uga.edu/ovpi. UGA Student Honor Code states, "I will be academically honest in all of my academic work and will not tolerate academic dishonesty of others." |