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Fundamentals of International Regulatory Affairs, Second Edition

  • Gain mastery of the global and multinational implications of regulatory
  • Understand developments in the harmonization of requirements and regulations by international bodies including the ICH, IMDRF and WHO

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As a regulatory professional, tackling the development of multinational products presents an increasingly complex challenge. Within the global scene, there continue to be significant developments in the harmonization of requirements and regulations by international bodies. ICH, IMDRF and WHO all...

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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