Clinical and Regulatory Affairs
Every drug, diagnostic test and medical device sold in the United States must meet a rigorous set of criteria to ensure quality and performance requirements. These standards are imposed by federal law and overseen by the Food and Drug Administration. Similar agencies regulate new product approvals in other countries. Although the process can be lengthy and expensive, patients needing medications and devices are relatively certain they are receiving safe, effective products of reliable quality. FDA monitoring continues even after these products have been approved for sale insuring that as more people use the product, issues such as appearance of rare side effects will be understood.
Topics in the Curriculum
Clinical Development: Phases 1-3 Studies
Accelerated Drug Approvals, Accessibility Programs
Biostatistics
Small Molecule Formulation
Clinical Trials Design
Drug Delivery Systems
Drug Master Files (DMF)
Good Clinical Practices (GCP)
Investigational New Drug Application (IND)
Common Technical Document (CTD)
Labeling, Packaging and Advertising
New Drug Application (NDA)
Post-approval Changes, Phase 4 Studies
Action letters and Pre-Approval Inspections (PAI)
Orphan Drug Development Program
International Regulatory Affairs
Standard Operating Procedures (SOPs)
Course Offerings for the Clinical and Regulatory Affairs Career Focus Track
Students may choose any combination of courses from the following list that comprise a total of at least four credits over both semesters.
ALS 401 Biotechnology-based Therapeutics (1 credit)
ALS 426 Medical Device Development and Market Release (1/2 credit)
ALS 431 Biostatistics Lab (no credit)
ALS 432 Writing an Orphan Drug Designation (1/2 credit)
ALS 433 Design of Clinical Trials (1/2 credit)
ALS 434 Clinical Biostatistics (1/2 credit)
ALS 435 Medical Device & Biologics Regulatory Affairs (1/2 credit)
ALS 437 Clinical Pharmacology I (1 credit)
ALS 438 Clinical Pharmacology II (1 credit)
ALS 461 Phase 1 Clinical Trials (1/2 credit)