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6.00 RAC

Pharmaceuticals: Canadian Regulations

This course will introduce you to essential areas of regulatory knowledge for a broad range of pharmaceutical, radiopharmaceutical and biologic products in Canada.


Credits:
6.00 RAC

  • List Price: $770.00
  • Member Price: $550.00

 
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This course will introduce you to essential areas of regulatory knowledge for a broad range of pharmaceutical, radiopharmaceutical and biologic products in Canada. You will learn about the Canadian regulatory framework and applicable legislation for prescription drugs, nonprescription drugs and...

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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