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Regulatory Affairs and Compliance

Certificate Program Online

Please note: Candidates choose either the Pharma or Device Track for their required courses.

Elective Courses

TitleWinterSpringSummerFall
Required Courses - Pharma Track
PHRMSCI X480
Introduction to Regulatory Affairs and Compliance for Drugs, Biologics, and Medical Devices (2 units)
PHRMSCI X480
  to be scheduled   Online
EECS X445.26
Regulatory Requirements for Pharmaceutical Products (3 units)
EECS X445.26
  to be scheduled Online Online
BIO SCI X450
Fundamentals of Clinical Trials (3 units)
BIO SCI X450
to be scheduled   Online  
PHRMSCI X481
Post-Approval Compliance Requirements for Pharmaceutical Products (2 units)
PHRMSCI X481
to be scheduled   Online  
Required Courses - Device Track
PHRMSCI X480
Introduction to Regulatory Affairs and Compliance for Drugs, Biologics, and Medical Devices (2 units)
PHRMSCI X480
  to be scheduled   Online
EECS X445.2
Regulatory Requirements for Medical Devices (3 units)
EECS X445.2
to be scheduled to be scheduled   Online
BME X413.2
Regulatory Affairs for Post-Market Approval (2 units)
BME X413.2
  to be scheduled    
BME X412
Regulatory Affairs Planning and Management: Concept Review and Evaluation (3 units)
BME X412
to be scheduled   Online  
Elective Courses (5 units)
PHRMSCI X493
Drug Safety and Pharmacovigilance (2 units)
PHRMSCI X493
to be scheduled      
MGMT X442.6
Medical Product Quality Systems (3 units)
MGMT X442.6
to be scheduled   Online  
MGMT X445
Medical Product Marketing (3 units)
MGMT X445
  to be scheduled   Online
PHRMSCI X490
Overview of Global Regulatory Affairs (3 units)
PHRMSCI X490
      Online
BME X414
Biomedical Business and Legal Management Essentials (3 units)
BME X414
    Online  
BME X408
Medical Product Life-Cycle Management (3 units)
BME X408
  to be scheduled   Online
PHRMSCI X495
Application of ICH Guidelines - Regulatory Strategy Development and Dossier Preparation (2 units)
PHRMSCI X495
    Online  

Course schedules are subject to change. Individual courses may be taken without enrolling in the full certificate.

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