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4.00 RAC


This introductory course provides an overview of US and global pharmacovigilance (PV) perspectives. You will learn the basic concepts, regulatory requirements, and recent trends and approaches, to understanding and communicating a drug safety profile.

4.00 RAC

  • List Price: $630.00
  • Member Price: $455.00

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Pharmacovigilance (PV)—the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems—is a dynamic and rapidly changing area of the pharmaceutical industry. As a critical component of ensuring consumer safety, the role of pharmacovigilance has been...

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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