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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
Post-Market Regulatory Obligations for Medical Devices 1.5
Medical Device Process Validation 2.0
Preparing for FDA Inspections and Conducting Sponsor Audits 1.5
Foundations in Medical Devices: Developing Premarket U.S. Regulatory Strategies and Working in a Regulated Environment 2.0
Communicating and Negotiating with the FDA 1.5
Value-Added Quality Audits 1.5
Global Medical Device Submissions and Strategy 1.5
Document Preparation: Protocols, Reports, Summaries 1.5
Immunology, Principles 3.0
Gene Therapy: Hacking the Genome 1.5
Quality Management Systems for Medical Devices: ISO 13485 and FDA Requirements 3.0
Clinical Statistics for Non-Statisticians 2.0
Design Control for Medical Devices 2.0
Regulation of in vitro Diagnostics in Europe and the US 2.5
Validating Software for Medical Devices and Emerging Technologies 2.0
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
Data Privacy and Security for Healthcare and Biosciences 1.5
European Medical Device Regulation: Clinical Evaluation and Post-Market Surveillance 3.0