The book is part of RAPS’ popular Fundamentals series, which also includes books on regulations in the US, EU and Japan, as well as a book on global standards.
Fundamentals of Canadian Regulatory Affairs, Fourth Edition reflects the changes in technology in the three years since the previous edition was published in 2011, and examines their impact on regulations. New chapters have been added on regulation of products for small patient populations, health technology assessment and reimbursement, development of products for pediatric populations and pharmacovigilance.
“This book’s four sections covering general information, drugs and biologics, medical devices and other product categories comprise just about everything relating to healthcare product regulation by Canadian authorities,” said RAPS Executive Director Sherry Keramidas, PhD, FASAE, CAE. “It is one reference everyone working with Canada’s regulations should definitely have.”
In addition to being a useful reference, many professionals preparing for the Canadian Regulatory Affairs Certification (RAC) exam cite Fundamentals as an important study tool.
Fundamentals of Canadian Regulatory Affairs, Fourth Edition is available both in print and as an e-book for $249.95 with free shipping for RAPS members, or $309.95, plus shipping, for nonmembers.
![“Another key [UDI] benefit, because we're calling that product by the same name across the healthcare supply chain… rich and robust data that we can access around supply consumption and utilization rates. One of the buzz terms we've heard during the COVID-19 crisis was what's my burn rate? How fast am I going through gowns, masks, gloves?” – Mike Schiller, Senior Director at AHRMM](https://img.healthcarepackaging.com/files/base/pmmi/all/image/2020/08/UDI.5f4d326e41d53.png?auto=format&fit=crop&h=146&w=340)
