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RAC (US) Instructor-Led Online Course
January 4, 2017 To April 13, 2017

Put your best effort forward for the RAC (US) exam with the new RAPS RAC (US) Instructor-Led Online Course. Experts in regulatory will lead you through four months of exam prep via live webinars.

  • List Price: $1,550.00
  • Member Price: $1,450.00
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During this instructor-led, planned course of study, you will participate in 16 weekly live regulatory webinars as you prepare to take the RAC (US) exam. Using the Fundamentals of US Regulatory Affairs book, with real-world examples and practical applications provided by regulatory experts, this...

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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