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Regulatory Affairs for Combination Products

Explore FDA's approach to regulation of combination products, the processes to streamline development of single entity, and aligning requirements between drugs and devices.

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概要

This on-demand training course will provide learners with an overview of FDA’s approach to the regulation of combination products, including a review of FDA’s recent guidance. Topics will cover processes to streamline and integrate the development of single-entity, co-packaged, and cross-labeled products, approaches to aligning requirements between drugs and devices, and assuring successful human factors interface. Course material will additionally address FDA’s expectation for post-marketing activities, including safety reporting and manufacturing modifications.

This on-demand training course takes an average of 8 hours to complete. Learners have access to the course for one year from the date of purchase.

特集トピック

  • Types of combination products
  • Regulatory route for approval
  • Regulatory pathways by center
  • Product development
  • Patient focus
  • Safety reporting
  • Working with FDA review centers
  • Post-approval changes
  • Good Manufacturing Practices for combination products

何を学ぶか

  • GMP compliance
  • Post-marketing safety
  • Post-approval changes
  • Streamlining device and drug systems
  • Specifications and design control
  • Risk assessment and management
  • Human factors interface

参加対象

This course is designed for professionals involved in:

  • Regulatory affairs
  • Clinical affairs
  • Quality assurance
  • Manufacturing and CMC
  • Safety and pharmacovigilance
  • Project management

学習目的

At the conclusion of this course, participants should be able to:

  • Recognize the similarities and differences in drug and device regulations
  • Identify opportunities to streamline single-entity compliance by integrating drug and device systems
  • Record risk assessment and management in the combination product environment
  • Define the unique requirements of successful combination product development
  • Determine FDA expectations of combination product applicants and how to work successfully with the agency
  • Identify how human factor considerations are assessed and controlled in the drug/device user interface
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