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MD-A 1: Australian Regulatory Affairs Overview
Description: An overview of Australian regulatory affairs.
Price: $179 (AUD)
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(Australian customers, please add GST.)
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Terms and conditions
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COURSE OUTLINE
INTRODUCTION
1. Welcome
2. Overview
3. Assessment
AUSTRALIAN REGULATIONS
4. Medical Device Industry
5. Historical Perspective
THE ESSENTIAL PRINCIPLES
6. Introduction
7. the Essential Principles Checklist
8. Specific Essential Principles
9. Applying the Essential Principles
10. Review
ROLES
11. Introduction
12. Manufacturer Responsibilities
13. Sponsor Responsibilities
14. TGA Responsibilities
15. Review
CLASSIFICATION AND CONFORMITY
16. Medical Device Classification
17. Conformity Assessment
18. Review
CONCLUSION
19. Summary
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COURSE OBJECTIVES
Students completing this course should be able to:
- Identify the Essential Principles
- Define the roles of the sponsor, manufacturer, and regulator
- Describe the classification systems of medical devices
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SeerPharma has partnered with GeneEd to now distribute courses in Major Therapeutic Areas, Clinical Research, and Biotechnology & Genetics.
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