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Executive Development Program at the Kellogg School of Management
Kellogg School of Management
2169 Campus Dr. James L. Allen Center Evanston, IL 60208
May 20-23, 2018
12.00 RAC

Designed specifically for the experienced regulatory professional, the RAPS Executive Development Program builds key management, business, and leadership skills through highly engaging learning with some of the world’s best business professors in an ultimate learning environment at the Kellogg School of Management at Northwestern University.

  • List Price: $8,050.00
  • Member Price: $7,600.00
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This one-of-a-kind program will challenge you and demand your best, ensuring a tangible return in investment. The knowledge you gain from this transformative program can provide immediate relevance and impact for you and your organization.

Key Areas Covered

The Kellogg School of Management brings...

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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