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4.00 RAC

Regulation of US & EU Biologics

This course examines the special characteristics of biologic products and the challenges associated with their development in the US and EU.


Credits:
4.00 RAC

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  • Member Price: $535.00

 
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This course examines the special characteristics of biologic products and the challenges associated with their development in the US and EU. It also introduces various aspects specific to their manufacturing, nonclinical and clinical development, and some global regulatory considerations that add...

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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