Perspectiva general

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.

Temas destacados

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

Lo que aprenderá

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This course is designed for professionals involved in:

Objetivos de aprendizaje

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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Regulatory Affairs for Combination Products

Perspectiva general

Temas destacados

Lo que aprenderá

¿Quiénes deben asistir?

Objetivos de aprendizaje

Be informed and stay engaged.