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2.00 RAC

Introduction to Regulatory Affairs in the US and Canada

This course provides an overview of healthcare product regulation across product lines and the applicable legislation that drives the regulatory processes in North America, specifically in the US and Canada.


Credits:
2.00 RAC

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This course provides an overview of healthcare product regulation across product lines in North America, specifically in the US and Canada. It highlights the agencies primarily responsible for regulating healthcare products—the US Food and Drug Administration (FDA) and Health Canada. The course...

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Fundamentals of US Regulatory Affairs, Eighth Edition

Table of Contents

Section I: General Information
Chapter 1 FDA and Related Regulatory Agencies
Chapter 2 History of Food, Drug and Cosmetic Law
Chapter 3 Overview of Drug, Biologic and Device Regulatory Pathways
Chapter 4 FDA Communications and Meetings
Chapter 5 Preparing for Key FDA Meetings and Advisory Committee Meetings
Chapter 6 Crisis Management
Chapter 7 Health Technology Assessment
Chapter 8 Good Laboratory Practice Regulations
Chapter 9 Clinical Trials: GCPs, Regulations and Compliance
Chapter 10 Current Good Manufacturing Practice and Quality System Design