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Fundamentals of International Pharmaceutical & Biologics Regulations

This publication focuses on international pharmaceutical and biologics regulations, requirements and guidelines, including ICH, ISO and PIC/S. It is derived from Fundamentals of International Regulatory Affairs, Third Edition.

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Dedicated to providing information on requirements, regulations and guidelines specific to pharmaceutical and biologics products on the international level, this is an excellent reference book for those new to the drug field or more experienced professionals needing to check a quick fact. It also...

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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