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4.00 RAC

Global Regulatory Strategy for Pharmaceuticals

This course provides a basic understanding of the challenges, tools and goals a regulatory professional must consider when defining a global regulatory strategy to get a product to market in the various regions.


Credits:
4.00 RAC

  • List Price: $630.00
  • Member Price: $455.00

 
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Understanding global demands from the perspective of regulators, patients, healthcare providers and payors is a necessity when creating a global regulatory strategy to support the development and marketing of a drug product. The concept of global, simultaneous marketing applications has moved from...

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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