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Comment Showing 25 courses for regulatory affairs.

Syllabus Library Detail View Calendar View
Course Quarter Units Fall Winter Spring Summer
Principles of Drug Discovery and Development 4.0
Science of Clinical Trials Design 2.5
Good Clinical Practices 3.0
Good Manufacturing Practices 3.0
Validating Software for Medical Devices and Emerging Technologies 2.0
Post-Market Regulatory Obligations for Medical Devices 1.5
Preparing for FDA Inspections and Conducting Sponsor Audits 1.5
Medical Device Process Validation 2.0
Foundations in Medical Devices: Developing Premarket U.S. Regulatory Strategies and Working in a Regulated Environment 2.0
Value-Added Quality Audits 1.5
Global Medical Device Submissions and Strategy 1.5
Immunology, Principles 3.0
Gene Therapy: Hacking the Genome 1.5
Clinical Statistics for Non-Statisticians 2.0
Quality Management Systems for Medical Devices: ISO 13485 and FDA Requirements 3.0
Design Control for Medical Devices 2.0
Regulation of in vitro Diagnostics in Europe and the US 2.5
Drug Safety and Adverse Events Reporting 1.5 Spring TBD
Mobile Health, SaMD, and AI/ML Devices 1.0
Risk Management for Regulated Industries 3.0
Regulatory Submissions: Devices and Diagnostics 2.5
Communicating and Negotiating with the FDA 1.5
Data Privacy and Security for Healthcare and Biosciences 1.5
Document Preparation: Protocols, Reports, Summaries 1.5
European Medical Device Regulation: Clinical Evaluation and Post-Market Surveillance 3.0