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RAC (US) Prep Virtual Program (Autumn 2017 Exam)
June 29, 2017 To October 16, 2017

Put your best effort forward for the autumn 2017 RAC (US) exam with the RAPS RAC (US) Prep Virtual Program. Experts provide comprehensive coverage of the topics on the RAC exam, including applied examples, case studies and Q&A sessions.

  • List Price: $1,225.00
  • Member Price: $1,125.00
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Registration is open now for the RAC (US) Prep Virtual Program (Autumn 2017 Exam), beginning on 29 June 2017. The new virtual format offers a more flexible schedule, so you can take notes and review topics at your own pace, and includes eight live Q&A sessions with regulatory experts who can...

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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