SMi Source Lesson Drug R&D: Combination Product Regulatory Requirements

  • SMi Source lesson Drug R&D: Combination Product Regulatory Requirements has the following microlearning topics

    • 1. Welcome

    2. Learning Objectives

    3. Regulatory Definitions

    4. Regulatory Definitions: Combination Product

    5. Knowledge Check: Product Descriptions

    6. Regulatory Classifications

    7. Regulatory Classifications: EU Regulatory Requirements

    8. Regulatory Classifications: Class II Devices

    9. Class II Devices: 513(g)

    10. Regulatory Classifications: Class II Devices

    11. Class II Devices: 510(k) Clearance

    12. Class III Devices

    13. Knowledge Check: Medical Devices

    14. Regulatory Classifications: Investigational Device Exemption (IDE)

    15. General Controls

    16. General Controls: Quality System Regulation (QSR)

    17. General Controls: Quality System Regulation (QSR)

    18. European Union Requirements (CE mark)

    19. Human Factors Studies

    20. Knowledge Check: Components of a Quality System

    21. Knowledge Check: Approved Medical Devices in the EU

    22. Knowledge Check: Classes of Medical Device

    23. Biological Product Regulation

    24. Biological Product Regulation: Biologics License Application (BLA), New Drug Application (NDA), Common Technical Document (CTD)

    25. Drug Regulation, Clinical Studies, CDT, and CMC

    26. Drug Regulation: European Registration International Conference on Harmonization (ICH)

    27. Knowledge Check: Most Common Submission Method

    28. Knowledge Check: Investigational New Drug Application

    29. Knowledge Check: New Drug Application (NDA)

    30. Knowledge Check: Drug Master File (DMF)

    31. Knowledge Check: CMC Document

    32. Combination Product Regulation

    33. Combination Products: Approval as Drug or Device

    34. Knowledge Check: Combination Product Classification

    35. Combination Products: Approval as Drug or Device?

    36. Combination Products: One or Two Submissions?

    37. Combination Products: One or Two Reviewers?

    38. Quality System Requirements/cGMPs

    39. Post-Marketing

    40. Product Disposal and Meetings with the FDA

    41. Knowledge Check: FDA Regulations

    42. Medical Products, Medical Device Regulation, Biological & Drug Product Regulation and Combination Product Regulation