Regulatory Science Core Thematic Areas

Competencies for regulatory science, which is a growing discipline in medical-related applications. Competencies for this complex field were identified and categorized into 11 Thematic Areas. These areas are based on a subset of the FDA’s priority areas and are accompanied by explanations of their development and broader recommendations to enrich education and training.

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Learning Objectives

The 11 Regulatory Science Thematic Areas:

  • Regulatory Science Research Questions and Priorities
  • Regulatory Policies and Process
  • Research Ethics
  • Drug Discovery and Development
  • Medical Device Innovation
  • Preclinical
  • Clinical Trials
  • Post-Marketing and Compliance
  • Analytical Approaches and Tools
  • Communication
  • Technology and Innovation
Competencies
Scientific concepts and research design
Ethical and participant safety considerations
Medicines development and regulation
Clinical trial operations
Study and site management
Data management and informatics
Leadership and professionalism
Communication and teamwork

Submitted by Russell Lackey, MS on Thu, 04/09/2020 - 10:25 . Last modified on 04/09/2020