Iâ€™m studying for my Health & Medical class and donâ€™t understand how to answer this. Can you help me study?
In 500 words reflect on what you have learned in this course. What was new to you and what interested you the most? Were you able to apply materials to your work if you are working in a clinical research or regulatory position? What did you find challenging?
- Explain the differences between the OHRP and the FDA’s requirements in the conduct of research
- Appraise the US FDA’s role governing the commercialization of medical products and the conduct of clinical trials
- Evaluate the regulatory context for the conduct of clinical research
- Analyze the structure of the Food and Drug Administration (FDA), including the FDA Committees and the functions of each major component of the organization
- Review the laws enforced by the FDA
- Evaluate the process of drug development
- Compare the types of approvals and characteristics of each pathway for regulated medical devices
- Evaluate the contribution of quality systems in product development and production
- Review the meaning of cGMP and the importance of cGMP in the manufacturing of medical devices
- Compare pathways to market for pharmaceutical products
- Understand the purpose and contents of an IND application
- Analyze the new drug application process.
- Explore U S regulatory agencies that take part in the regulation of particular aspects of these products (such as print advertising)
- Reflect on the impact of the availability of resources and enforcement discretion by a regulatory agency in carrying out its mission.
- Discuss the conduct of ethical clinical research and the associated regulations during the product development process.
- Summarize the membership requirements, ethical obligations, and regulatory oversight of an Institutional Review Board.
- Evaluate the impact of GCPs on the conduct of clinical research.
- Review the regulatory requirements for biological products and dietary supplements.
- Gain a deeper understanding of the medical devices that are categorized as “diagnostic” devices.
- Apply the regulatory framework to understand and compare the requirements for evaluating these products.