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2.00 RAC

Regulation of Biosimilars

This first part of the course examines the sources of complexity in biologics and their production processes. The remainder of the course compares the current guidances (2013) and discuss the quality, nonclinical and clinical aspects of biosimilar development in three major regulatory jurisdictions, namely the EU, US and Canada.

2.00 RAC

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The biosimilar approval process is complex and evolving. As a result, regulatory agencies and manufacturers have to collaboratively understand the issues arising from biologic products that are similar but not identical, that will insure their safety and efficacy.

This first part of the course...

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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