Back to Global Pharmaceutical & Biologics Regulation, Vol. 1 & 2

Global Pharmaceutical & Biologics Regulation, Vol. 1 & 2

  • Reference comprehensive information about pharmaceutical and biologics regulation in this two-volume guide
  • Adapted from the definitive Fundamentals of Regulatory Affairs series

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The world of pharmaceutical and biological product regulations presents even seasoned regulatory pros with unique challenges. Overcome them with RAPS’ guide to Global Pharmaceutical and Biologics Regulation, First Edition.

Featuring materials adapted from RAPS’ five book series Fundamentals of...

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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