Back to On-demand Webcast: Driving RI to New Levels and Moving to a Dynamic RA/QA Environment
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On-demand Webcast: Driving RI to New Levels and Moving to a Dynamic RA/QA Environment

An on-demand recording of the RAPS Webcast, Driving RI to New Levels and Moving to a Dynamic RA/QA Environment, originally recorded on 12 October 2016.


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New innovative technology regulatory intelligence (RI) tools change the way you use and see data. We have moved from a static to a dynamic regulatory environment and the right technology can help you driving RI to new levels. RI technology is creating the opportunity to enhance intelligence and...

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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