Custom E-Book: RWU BIOTEC 560 - Fall 2026

This custom e-book was created exclusively for the Introduction to Regulatory Affairs course at Roger Williams University. It features selected chapters from two RAPS Fundamentals titles:

• Fundamentals of Medical Device Regulations: A Global Perspective
  • Includes Chapters: 1, 2, 3, 4, 5, 10, 21, 22, 26, 29, 30, 31, 35, and 37

• Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective, Second Edition
  • Includes Chapters: 1, 2, 5, 12,17,18, 25,27, 32, 35, and the Glossary, Abbreviations, and Acronyms

Designed to support the Fall 2026 curriculum, this e-book provides foundational insights into global regulatory frameworks for both medical devices and pharmaceutical/biologic products.