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3.00 RAC

Introductory Medical Writing

During this course, you will obtain an overview of the medical writing profession from a regulatory perspective, including an introduction to the basic skills important for medical writing in that field.

3.00 RAC

  • List Price: $495.00
  • Member Price: $360.00

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Regulatory writing is a skill that must be honed and refined as one gains regulatory knowledge and experience. Regulatory professionals prepare highly detailed documents that are pivotal to the approval and marketing of healthcare products around the world. For those with an aptitude for clear 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