| Course ID: | PHAR 6310E. 3 hours. |
| Course Title: | Good Clinical Practice Regulations for Drugs, Biologic Products, and Medical Devices |
Course
Description: | Review of the United States and European Good Clinical
Practices regulations that apply to conducting clinical trials
for drugs, biologic products, and medical devices involving
human subjects. Knowledge and understanding of the regulations
and compliance challenges associated with conducting human
clinical studies from a regulatory affairs perspective. |
| Oasis Title: | GOOD CLIN PRAC REG |
| Nontraditional Format: | Three hours per week for fifteen weeks online study, including
teaching, assignments, discussion, problem-based learning, and
case-based learning. Weekend seminars totaling eight contact
hours (onsite or multi-point video/web conference) utilizing
case-based and problem-based learning methods. |
| Prerequisite: | (PHAR 6010 and PHAR 6020 and PHAR 6030) or permission of department |
| Grading System: | A-F (Traditional) |
|
| Course Objectives: | Compare and contrast the regulations governing the protection of
human subjects enrolled in clinical studies, including:
- Informed Consent Required Elements
- Informed Consent Documents for clinical studies
Discuss the Food and Drug Administration’s regulations for
Institutional Review Boards, including:
- The duties and responsibilities of the IRB
- Sponsor responsibilities for communicating with IRBs
- Interactions between IRBs and FDA
Categorize the regulations and requirements of financial
disclosure for clinical investigators, including:
- Financial interest and reporting thresholds
- Documents that must be retained by the sponsor
Demonstrate a working knowledge of the E6 Good Clinical Practice
Consolidated Guidance including;
- How E6 relates to FDA requirements for GCP
- How local regulations are addressed globally
Locate GCP reference materials required of regulatory affairs
professionals.
Appraise the subjective and interpretative aspects of
regulations
in order to think critically about GCP Compliance. |
| Topical Outline: | - The FDA: Organization, Key legislation, and Enforcement
Powers
- Overview of the IDE Regulations and Introduction to GCPs
- Sponsor Responsibilities and Required Reports in Clinical
Studies
- Investigator Responsibilities, Informed Consent, and Financial
Disclosure
- Clinical Trial Monitoring
- BioResearch Monitoring and Enforcement
- European Regulations: A Global Perspective & ISO 14155
- E6 Good Clinical Practices: Essential Documents & Auditing
- Good Clinical Practices: Drugs & Biologics
- A Global Approach: GCPs for Drugs and Biologics
- GCP Proposal
- Final Exam |
| 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." |