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.

The Clinical and Regulatory Affairs focus track provides an understanding of how the FDA and its international counterparts regulate the development of novel products including assessment of product quality, non-clinical and clinical evaluation.

Career Options
Advertising, Marketing
Clinical Research Organizations (CRO)
Clinical Trial Monitoring and Management
Compliance
Product Development
Product Management
Project Management
Quality Control/Quality Assurance
Regulatory Affairs
Regulatory Intelligence

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

Technical Courses
Students may choose any combination of courses from the following list that comprise a total at least four units over both semesters.

ALS 435 U.S. Regulatory Affairs (1/2 course)
ALS 401 Biopharma: Biotechnology-based Therapeutics
ALS 426 Medical Device Development and Market Release (1/2 course)
ALS 436 Small Molecule Regulatory Affairs (1/2 course)
ALS 437 Introduction to Clinical Pharmacology I (1/2 course)
ALS 438 Introduction to Clinical Pharmacology II (1/2 course)
ALS 433 Clinical Trials Design, Conduct and Strategy (1/2 course)
ALS 434 Clinical Biostatistics (1/2 course)

Business Courses
Students may choose any combination of courses from the following list that comprise a total at least two units over both semesters.
ALS 452 Applied Entrepreneurship Practicum* (1/2 course)
ALS 454 International Business and Global Health
ALS 455 Building a Biomedical Enterprise
ALS 456 Managing Strategic Networks
ALS 458 Applied Entrepreneurship**
ALS 459 Project Management (1/2 course)

*ALS 452 may count as a business/management course only with permission of the faculty instructor.
**ALS 458 begins in October and continues through March for a total of one course unit.