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5.00 RAC

Pharmaceuticals: US Regulations

Knowledge is power. Get a better understanding of pharmaceuticals and up-to-date regulatory processes, while focusing on the topics that are relevant for you. This course will also help you get a basic understanding of the IND, NDA, and how FDA is organized and interacts with pharmaceutical companies.


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5.00 RAC

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Whether you are new to US pharmaceutical regulations or have been working in this field for some time, having the right tools and abilities to overcome challenges and meet professional expectations can be a never ending struggle. Get an in-depth understanding of pharmaceuticals in the US, beginning...

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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