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3.00 RAC


The course provides an overview of the history, philosophy and regulatory requirements behind risk management programs in the US and EU—Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMPs), respectively—and the developing framework for risk management activities in Canada.

3.00 RAC

  • List Price: $495.00
  • Member Price: $360.00

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Over the past decade, risk management has gained increased global visibility due to several high-profile drug safety issues; however, risk management tools have been used since the beginning of modern drug development. More-stringent risk management tools—boxed warnings, market withdrawal, patient...

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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