Regulatory Affairs - CPS (RGA)

Code	Title	SH	Prerequisites
RGA 1010	U.S. Regulatory Systems and Agencies	3
RGA 1050	Regulatory Policy Development	3
RGA 1080	Pharmaceutical Regulatory Affairs	3
RGA 3000	Introduction to Safety Science	3
RGA 3300	Strategic Planning and Project Management for Regulatory Affairs	3
RGA 6000	Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation	2
RGA 6001	Introduction to Food and Drug Administration (FDA) Medical Device Regulation	2
RGA 6002	Introduction to Regulatory Compliance and Practice	2
RGA 6101	Therapeutic Product Development: A Regulatory Overview	4	all of: RGA 6000 (min C-) BTC 6210 (min C-)
RGA 6105	Introduction to Regulatory Compliance and Practice	3
RGA 6150	Regulatory Strategy for Product Development and Life-Cycle Management	3
RGA 6202	Medical Device Development: A Regulatory Overview	4	all of: BTC 6210 (min C-) (may be taken concurrently) RGA 6001 (min C-) (may be taken concurrently)
RGA 6203	Pharmaceutical and Medical Device Law: Topics and Cases	5	one of: RGA 6101 (min C-) (may be taken concurrently) RGA 6202 (min C-) (may be taken concurrently)
RGA 6204	Legal Issues in International Food, Drug, and Medical Device Regulation	5	one of: RGA 6101 (min C-) (may be taken concurrently) RGA 6202 (min C-) (may be taken concurrently)
RGA 6205	Emerging Trends and Issues in the Medical Device Industry	4	RGA 6202 (min C-)
RGA 6207	Global Impact of Electronic Common Technical Document (eCTD) Submissions	4	all of: RGA 6101 (min C-) BTC 6210 (min C-)
RGA 6208	Introduction to Safety Sciences	3
RGA 6210	Strategic Planning and Project Management for Regulatory Affairs	4	one of: RGA 6202 (min C-) RGA 6101 (min C-)
RGA 6212	Introduction to Safety Sciences	4	all of: RGA 6002 (min C-) RGA 6463 (min C-)
RGA 6215	Project Management in Early Drug Discovery and Development	4	one of: RGA 6101 (min C-) RGA 6202 (min C-)
RGA 6217	Biomedical Product Development: From Biotech to Boardroom to Market	4	one of: RGA 6101 (min C-) RGA 6202 (min C-)
RGA 6219	Advanced Topics in Advertising and Promotion of Drugs and Medical Devices	4	one of: RGA 6101 (min C-) RGA 6202 (min C-)
RGA 6221	European Union Compliance Process and Regulatory Affairs	4	one of: RGA 6203 (min C-) RGA 6204 (min C-)
RGA 6222	European Medical Device Regulations	4	one of: RGA 6203 (min C-) RGA 6204 (min C-)
RGA 6223	Introduction to Australian, Asian, and Latin American Regulatory Affairs	4	one of: RGA 6101 (min C-) RGA 6202 (min C-)
RGA 6224	Regulation of Biomedical Product Commercialization by Health Canada	4	one of: RGA 6202 (min C-) RGA 6101 (min C-)
RGA 6228	Managing International Clinical Trials	4	BTC 6210 (min C-)
RGA 6233	Application of Quality System Regulation in Medical Device Design and Manufacturing	4	one of: RGA 6101 (min C-) RGA 6202 (min C-)
RGA 6234	Risk Management: Compliance and Processes	4	one of: RGA 6000 (min C-) RGA 6001 (min C-)
RGA 6235	Emerging Product Categories in the Regulation of Drugs and Biologics	4	one of: RGA 6101 (min C-) RGA 6202 (min C-)
RGA 6238	Human Experimentation Methodological Issues Fundamentals	3
RGA 6243	Medical Device Product Development in Canada	4	one of: RGA 6001 (min C-) RGA 6202 (min C-)
RGA 6244	Therapeutic Product Development in Canada	4	RGA 6002 (min C-)
RGA 6275	Product Development and Process Validation	2	all of: RGA 6002 (min C-) one of: RGA 6000 (min C-) RGA 6001 (min C-)
RGA 6285	Validation and Auditing of Clinical Trial Information	3	( one of: RGA 6610 (min C-) RGA 6600 (min C-) ) or BTC 6210 (min C-) and ( one of: RGA 6000 (min C-) RGA 6001 (min C-) )
RGA 6290	Clinical Trial Design Optimization and Problem Solving	3	RGA 6238 (min C-) and ( one of: RGA 6610 (min C-) RGA 6600 (min C-) ) or ( all of: BTC 6210 (min C-) RGA 6000 (min C-) ) or RGA 6001 (min C-)
RGA 6295	Managing International Clinical Trials	3	RGA 6238 (min C-) and ( one of: RGA 6610 (min C-) RGA 6600 (min C-) ) or BTC 6210 (min C-)
RGA 6300	Practical Applications in Global Regulatory Affairs	4	one of: RGA 6203 (min C-) RGA 6204 (min C-)
RGA 6308	Pharmaceutical and Medical Device Law: Topics and Cases	3	one of: all of: RGA 6105 (min C-) RGA 6150 (min C-) one of: RGA 6101 (min C-) (may be taken concurrently) RGA 6202 (min C-) (may be taken concurrently)
RGA 6350	Legal Issues in International Food, Drug, and Medical Device Regulation	3	one of: all of: RGA 6002 (min C-) RGA 6463 (min C-) all of: RGA 6105 (min C-) RGA 6150 (min C-)
RGA 6370	Advanced Regulatory Writing: Medical Device Submissions	4	RGA 6202 (min C-)
RGA 6380	Advanced Regulatory Writing: New Drug Applications	4	RGA 6101 (min C-)
RGA 6400	Medical Device Product Development and Process Validation	2	one of: all of: one of: RGA 6000 (min C-) RGA 6001 (min C-) RGA 6002 (min C-) all of: RGA 6208 (min C-) RGA 6238 (min C-)
RGA 6405	Nonclinical Regulations in Biomedical Product Commercialization	4	all of: RGA 6002 (min C-) RGA 6463 (min C-)
RGA 6410	Fundamentals of CMC Regulations and Methods	4	one of: RGA 6101 (min C-) RGA 6202 (min C-)
RGA 6415	Fundamentals of CMC Regulations and Methods	2	one of: one of: RGA 6101 (min C-) RGA 6202 (min C-) all of: RGA 6208 (min C-) RGA 6238 (min C-)
RGA 6420	Global IVD Regulations and Submissions	4	RGA 6202 (min C)
RGA 6435	Medical Device Cybersecurity and Digital Health	2	one of: one of: RGA 6101 (min C-) RGA 6202 (min C-) all of: RGA 6208 (min C-) RGA 6238 (min C-)
RGA 6440	Advanced Topics in Advertising and Promotion of Drugs and Medical Devices	2	one of: one of: RGA 6101 (min C-) RGA 6202 (min C-) all of: RGA 6208 (min C-) RGA 6238 (min C-)
RGA 6450	Financing and Reimbursement in Biomedical Product Development	2	all of: RGA 6208 (min C-) RGA 6238 (min C-)
RGA 6461	Cybersecurity and Regulation of Digital Health Technologies by the FDA	2	one of: RGA 6101 (min C-) RGA 6202 (min C-)
RGA 6463	Regulatory Strategy for Product Development and Life-Cycle Management	4
RGA 6465	Nonclinical Regulations in Biomedical Product Commercialization	2	one of: all of: RGA 6002 (min C-) RGA 6463 (min C-) all of: RGA 6208 (min C-) RGA 6238 (min C-)
RGA 6475	Strategic Planning and Project Management for Regulatory Affairs	2	one of: one of: RGA 6202 (min C-) RGA 6101 (min C-) all of: RGA 6208 (min C-) RGA 6238 (min C-)
RGA 6480	Real-World Evidence and Patient-Reported Outcomes in Regulatory Decision Making	2	one of: all of: BTC 6210 (min C) one of: RGA 6000 (min C) RGA 6101 (min C) all of: RGA 6208 (min C-) RGA 6238 (min C-)
RGA 6490	Emerging Trends and Challenges in Regulatory Affairs	2	one of: RGA 6202 (min C-) all of: RGA 6208 (min C-) RGA 6238 (min C-)
RGA 6500	Biomedical Product Development: Regulatory Affairs in a Market-Based Setting	2	one of: one of: RGA 6101 (min C-) RGA 6202 (min C-) all of: RGA 6208 (min C-) RGA 6238 (min C-)
RGA 6600	Introduction to Food and Drug Administration Pharmaceutical Regulation	3
RGA 6610	Introduction to Food and Drug Administration Medical Device Regulation	3
RGA 6620	Medical Device Development: A Regulatory Overview	3	one of: RGA 6610 (min C-) all of: BTC 6210 (min C-) RGA 6001 (min C-)
RGA 6630	Medical Device Quality Management System: Principles and Applications	3	one of: RGA 6610 (min C-) one of: RGA 6101 (min C-) RGA 6202 (min C-)
RGA 6640	Risk Management: Compliance and Processes	3	one of: RGA 6610 (min C-) RGA 6000 (min C-) RGA 6001 (min C-)
RGA 6650	Medical Device Product Development in Canada	3	one of: one of: RGA 6001 (min C-) RGA 6202 (min C-) all of: RGA 6105 (min C-) RGA 6150 (min C-)
RGA 6660	Therapeutic Product Development: A Regulatory Overview	3	one of: RGA 6600 (min C-) all of: RGA 6000 (min C-) BTC 6210 (min C-)
RGA 6670	Global Impact of Electronic Common Technical Document (eCTD) Submissions	3	one of: RGA 6600 (min C-) all of: RGA 6101 (min C-) BTC 6210 (min C-)
RGA 6675	Therapeutic Product Development in Canada	3	one of: all of: RGA 6105 (min C-) RGA 6150 (min C-) RGA 6002 (min C-)
RGA 6680	Project Management in Early Drug Discovery and Development	3	one of: RGA 6600 (min C-) RGA 6101 (min C-) RGA 6202 (min C-)
RGA 6685	European Medical Device Regulations	3	one of: one of: RGA 6203 (min C-) RGA 6204 (min C-) all of: RGA 6105 (min C-) RGA 6150 (min C-)
RGA 6690	Global In Vitro Diagnostic Regulations and Submissions	3	one of: RGA 6202 (min C-) RGA 6650 (min C-)
RGA 6962	Elective	1–4
RGA 6980	Capstone: Practical Applications in Global Regulatory Affairs	3	( one of: RGA 6238 (min C-) BTC 6210 (min C-) ) and ( one of: RGA 6308 (min C-) RGA 6203 (min C-) ) or ( one of: RGA 6350 (min C-) RGA 6204 (min C-) )
RGA 7100	Regulatory Frameworks for Biomedical Product Development	3
RGA 7110	Biomedical Product Post-Market Regulatory Strategy	3
RGA 7120	Multi-Stakeholder Perspectives in Biomedical Product Access	3
RGA 7130	Research Methodologies in Regulatory Affairs	3
RGA 7962	Elective	1–4
RGA 7983	Topics	1–4

Instructors are from recent scheduled terms; each course page shows them per season with student shares. Blank means no recent scheduled sections on record.