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RAC (EU) Practice Exam

Online interactive RAC (EU) practice exam with coaching report designed to assist you in your preparation and simulate the exam experience.

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Put your regulatory skills to the test. This comprehensive practice exam contains 100 multiple-choice questions formulated by recall, application and analysis across the RAC (EU) exam’s three major subject area domains. It is designed to familiarize you with the types of questions and content found...

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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