Back to On-demand Webcast: How to Effectively Talk to Regulators

On-demand Webcast: How to Effectively Talk to Regulators

An on-demand recording of “How to Effectively Talk to Regulators”, sponsored by 3D Communications, originally recorded on 25 October 2017.
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A communication with a government agency is the wrong time for an original thought!

Often, industry finds itself in an antagonistic situation with government agencies or its regulators. There could be an emerging safety issue, concerns about packaging, or supply chain challenges....

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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