Meeting Details

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Indiana Chapter: Raising the Regulatory Voice–Persuasive Framing
January 30, 2018
1:00 PM - 2:00 PM ET
1.00 RAC
  • List Price: $30.00
  • Member Price: $20.00
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Regulatory professionals have complicated jobs with many types of demands; tight timelines, divisional overlap and complex project plans. It’s therefore critical that regulatory professionals be persuasive, engaging and influential within their companies and health authorities. The first step in...

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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