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RAC (US) Prep Toolbox

The RAC (US) Prep Toolbox brings together a full range of valuable resources to help you identify your strengths and gap areas, gives you a sense for the kinds of questions you will be tested on and clarifies how the exam is structured.

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Like anything worth having, earning the RAC won’t be easy. You need a plan and the right resources. The RAC (US) Prep Toolbox has just the right stuff to get you there.

The Toolbox brings together a full range of valuable resources to help you identify your strengths and gap areas, gives you a...

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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