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2.00 RAC

Role of the Regulatory Professional

This course discusses the evolution of the regulatory profession, the professional’s roles and responsibilities and provides an updated snapshot of the scope of practice in which they work.


Credits:
2.00 RAC

  • List Price: $25.00

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Regulatory professionals play critical roles in the health product lifecycle, from development through postapproval. The regulatory professional’s job is to keep track of the ever-changing regulations in all of the regions or countries in which the company wishes to distribute its products....

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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