Combination Products (Drugs, Devices and Biologics) – Part 2
Description:
This course will provide an in-depth explanation of combination products, including regulatory definitions, applicable regulations, the regulatory submission process, clinical trials, and manufacturing and GMP considerations. In addition, we’ll provide links to more in-depth information on certain topics as we move through the course.
An additional goal of this course is to provide an understanding and overview of the variety of regulatory and review challenges presented by combination products as compared with single-entity products.
Curriculum for this course:
Introduction
| Course Overview | 1 min 01 secs |
| Learning Objectives | 1 min 09 secs |
| Who Should Take This Course? | 1 min 11 secs |
| Terms Explained | 50 secs |
| Course Modules | 52 secs |
Module 3: Regulatory Submission Pathway
| Lead Center Assignment | 1 min 15 secs |
| Product Examples | 1 min 08 secs |
| What Determines the Marketing Authorization Type for Combination Products? | 1 min 20 secs |
| FDA Guidance on Premarket Pathways for Combo Products | 1 min 14 secs |
| Clarity on Pre-market Interactions with the FDA | 1 min 07 secs |
| Pre-market Submissions for Combination Products | 1 min 37 secs |
| Annex: Examples of Device-Led Combination Products | 1 min 11 secs |
| Electronic Application Format | 1 min 09 secs |
| Early Interaction / Feedback – Part 1 | 1 min 02 secs |
| Early Interaction / Feedback – Part 2 | 1 min 14 secs |
Module 4: Clinical Trials
| Clinical Trial Considerations | 1 min 01 secs |
| Device Constituent Parts | 1 min 11 secs |
| Drug and Biological Product Constituent Parts | 1 min 21 secs |
| Additional Drug/Device Considerations | 59 secs |
| Clinical Investigation | 1 min 02 secs |
| Oversight of Clinical Investigations | 1 min 20 secs |
| Human Factor Studies | 1 min 29 secs |
| FDA Human Factors Guidance – Part 1 | 49 secs |
| FDA Human Factors Guidance – Part 2 | 1 min 14 secs |
| Sterility Requirements | 1 min 07 secs |
| Stability Requirements for Combination Products | 1 min 30 secs |
| Stability Testing for Combination Products | 1 min 15 secs |
| Special Considerations for Stability Testing – Part 1 | 1 min 25 secs |
| Special Considerations for Stability Testing – Part 2 | 1 min 20 secs |
| General CMC Issues for Combination Products | 1 min 18 secs |
Conclusion
Final Assessment
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-146 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
The section on the FDA guidance was very helpful to my staff, this course coupled with parts 1 and 3 are a key part of our training strategy for combination products.
Loved this course and the ease at which a complex topic was discussed. Great job!
Related courses:
Combination Products (Drugs, Devices and Biologics) – Part 1
ISO 13485:2016 – Chapter 1-3: Introduction
ISO 13485:2016 – Chapter 4: The Quality Management System (QMS)
ISO 13485:2016 – Chapter 5: Management Responsibility
ISO 13485:2016 – Chapter 6: Resource Management
ISO 13485:2016 Product Realization (Chapter 7 – Part A)
ISO 13485:2016 – Product Realization (Chapter 7 – Part B)
ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part A)
ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part B)
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