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4.00 RAC

Regulation of IVDs for Key International Markets

This course will cover IVD regulatory requirements in three key markets—Europe, Canada and Japan.


Credits:
4.00 RAC

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

 
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This course will cover IVD regulatory requirements in three key markets—Europe, Canada and Japan. Key topics within each market include IVD risk classifications, manufacturer’s premarket responsibilities, labeling requirements and post-market surveillance requirements. The unique regulatory...

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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