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Giving Voice to Regulatory Leadership (On-demand Webcast)

An on-demand recording of the RAPS Webcast, Giving Voice to Regulatory Leadership, originally recorded on 6 May 2015.


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The most valued regulatory professionals are more than technically competent. They have multiple regulatory voices depending on the situation—team member, leader and facilitator—especially across a wide array of health authority, compliance, cultural, ego, cross-functional 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