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Regulatory Affairs for Combination Products


This introductory course will provide learners with an overview of FDA’s approach to regulation of combination products including review of FDA’s recent guidance. Topics will cover processes to streamline and integrate development of single entity, co-packaged and cross-labeled products. Discussion will cover approaches to aligning requirements between drugs and devices and assuring successful human factors interface. Course material will address FDA’s expectation for post-marketing activities, including safety reporting and manufacturing modifications. Workshops will offer practical applications in when and how to report as a constituent product or as a combination.

What you will learn

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

Who should attend?

This course is designed for professionals in:

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

Learning objectives

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

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

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