MSPS 531Regulatory Affairs

Marshall University · 3 credits · UGRD

Catalog

An overview of USFDA's regulation on drug. Topics covered include pharmaceutical regulatory agencies and organizations around the world and their International Regulatory Audits for Pharma, International Conference on Harmonization (ICH) guidelines, Pharmacopoeias and national formulary, US Food and Drug Administration (USFDA): History of USFDA Law and Regulation, GLP, MMP, NDA, and ANDA.

Recent sections

Fall 2026 · 1 section

Aug 17 – Dec 11

Section	Days & time	Location	Instructor
101Class #2741	Tu Th · 4:00 – 5:15 PM	SH 108	Jones, Cynthia