Back to On-Demand Webcast: Ask a RAPS Fellow: Industry Leaders Share Their Insight on the Profession
1.00 RAC

On-Demand Webcast: Ask a RAPS Fellow: Industry Leaders Share Their Insight on the Profession

On-Demand Webcast: Ask a RAPS Fellow: Industry Leaders Share Their Insight on the Profession

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1.00 RAC

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Friday, 21 October 2016
2:00–3:00 pm EST

Who better to receive regulatory career development advice from than a RAPS Fellow? How about four RAPS Fellows. The panel members of this interactive webcast provide insights that could help shape your career path. The Fellows talk about their professional...

Back to On-Demand Webcast: Ask a RAPS Fellow: Industry Leaders Share Their Insight on the Profession
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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