Back to On-demand Webcast: Advancing and Enabling Regulatory Science to Impact Policy at CDRH: The AIMBE FDA Scholars Program
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On-demand Webcast: Advancing and Enabling Regulatory Science to Impact Policy at CDRH: The AIMBE FDA Scholars Program

An on-demand recording of the RAPS Webcast, Advancing and Enabling Regulatory Science to Impact Policy at CDRH: The AIMBE FDA Scholars Program, originally recorded on 29 November 2016.


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The American Institute for Medical and Biological Engineering (AIMBE) Scholars are post-PhD graduates who work directly in FDA’s Center for Devices and Radiological Health (CDRH) and have an opportunity to influence the development of various future regulations. They will share what was required to...

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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