Good Clinical Practice Regulations for Drugs, Biologic Products, and Medical Devices
PHAR 6310E
3 hours
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.
Athena Title
Good Clinical Practice Regulat
Non-Traditional Format
This course will be taught 95% or more online.
Prerequisite
(PHAR 6010 and PHAR 6020 and PHAR 6030) or permission of department
Grading System
A - F (Traditional)
Student learning Outcomes
Students will understand how to 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
Students will understand how to 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
Students will understand how to 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
Students will understand how to 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
Students will understand how to locate GCP reference materials required of regulatory affairs professionals.
Students will understand how to 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 and ISO 14155
- E6 Good Clinical Practices: Essential Documents and Auditing
