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RAPS Indiana Chapter: Addressing Global Health Needs—Challenges and Opportunities
Purdue University
516 Northwestern Avenue West Lafayette, IN 47906
May 17, 2017
5:30 PM - 8:00 PM ET
2.00 RAC
  • List Price: $40.00
  • Member Price: $25.00
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Come join us to connect with others from your local regulatory community and hear an interactive presentation on health needs from a global perspective. This session is brought to you by the RAPS Indiana Chapter and is intended to promote engagement between government, industry and academia. A...

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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