Regulatory Affairs Course Schedule

 This chart outlines the program curriculum and annual schedule. Click here to read course details and enroll.
 19-unit minimum ■ = classroom   O = online   ▲ = hybrid
☐ = both online and classroom sections available
Required Courses (seven) Units Course Fall Winter Spring Summer
Drug Development Process 2.0 6559 ■ ■ ■ ■
Regulation of Medical Devices and Diagnostics 3.0 19071 ■ ■  
Regulation of Drugs and Biologics 3.0 19007 ■   ■  
 
One of the following*
*Regulatory Submissions: Drugs and Biologics OR
 2.0 19067 ■   ■  
*Regulatory Submissions: Devices and Diagnostics 2.5 19315   ■
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One of the following*
*Good Manufacturing Practices OR
 3.0 6328   ■   ■
*Regulatory Compliance for Medical Devices 2.5 19029 ■   ■  
 
Interacting with the FDA 1.5 19318   ■   ■
RA Professional's Toolbox 1.5 19317 ■   ■  
 *The remaining submissions or compliance courses may be used as electives.

 

Elective Courses (4 units required) Units Course Fall Winter Spring Summer
Regulatory
Drug Quality Fundamentals 1.5 23400 ■      
Electronic Records for Regulated Environments: Cost-Effective Approaches to Compliance 1.5 19362  ■   ■  
Global Medical Device Submissions and Strategy 1.5 20343     ■
Human Factors and Usability in Medical Device Development 2.0 23097   ■   ■
Medical Device Verification and Validation 1.5 30042 ■  
Medical Writing 2.0 4451
 
Mobile Medical Applications 0.5 30045   ■   ■
Post-Market Regulatory Obligations for Medical Devices 1.5 22414 ■   ■
  
Regulation of Biomedical Product Advertising, Promotion and Labeling 1.5 20756 ■    
Regulatory Intelligence 1.0 20341       ■
Risk Management for Regulated Industries 3.0 22631   ■   ■
Value-Added Quality Audits 1.5 19073       ■
 
Clinical
Adverse Event and Medication Coding: An Introduction to MedDRA®, COSTART, and WHO-Drug 1.5 19976     ■  
Clinical Statistics for Non-Statisticians 2.0 2345   ■   ■
Drug Safety and Adverse Events Reporting 1.0 3990 ■ ■    
Electronic Data Capture for Clinical Trials 1.0 20777   ■    
Global Conduct of Clinical Trials 1.5 20787 ■   ■  
Good Clinical Practices 3.0 0458 ■ ■ ■  
Preparing for FDA Inspections and Conducting Sponsor Audits 1.5 5168
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Science of Clinical Trials Design 2.5 3657 ■
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Discovery/Development (A maximum of 1.5 units may be applied to the elective requirement)
Intellectual Property Essentials for the Life Science Industry 1.0 1942     ■  
Medical Device Design and Development 2.0 19977 ■   ■  
Toxicology Basics for Biotechnology 1.5 2310       ■

 

Free Events Units Course Fall Winter Spring Summer
Biosciences Program Presentation: Biotechnology and Bioinformatics   16649
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Clinical Trials, Regulatory Affairs, and Medical Devices Program Presentation   16650
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Note: Individual courses may be taken without enrolling in the full certificate. Course schedule is subject to change, but reflects the current quarter and the anticipated schedule for the next three quarters. Check individual course descriptions for the latest scheduling information.

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Biosciences