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Sponsored Webcast: How to Effectively Talk to Regulators
October 25, 2017
12:00 PM - 1:30 PM ET
1.50 RAC
This webcast will provide insight into the dos and don’ts of communicating with a regulator, including examples of industry effectively working with FDA.
  • List Price: Free

25 October 2017
12:00–1:30pm EDT

Sponsored by:

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...

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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