A Kaplan EduNeering course

This course will provide an overview and summary of the regulatory history and requirements by the Food and Drug Administration (FDA) and International Conference on Harmonization (ICH), which are necessary to ensure proper and successful clinical trial execution.  This module is also designed to take you through some of the history behind today’s system of drug and device development.  It is important to provide you with this perspective so that you can recognize how the industry and the FDA have evolved.  Review of (ICH) will also provide you with an understanding of its impact on the industry form a global perspective.

Topics include:
      ·          Setting standards
      ·          Organizations
      ·          Regulations
      ·          Guidelines

Linda Belmont at DIA