BML760
| BML760 | |
|---|---|
| Biomedical Ethics, Safety and Regulatory Affairs | |
| Credits | 2 |
| Structure | 2-0-0 |
| Pre-requisites | |
| Overlaps | |
BML760 : Biomedical Ethics, Safety and Regulatory Affairs
[edit]Introduction to medical ethics and bioethics, environmental ethics. Use of animals in pre-clinical trials and ethical approval. Ethics issues in biomedical sciences (inhalable, injectable, implantable systems). Principles of biosafety. Biosafety cabinets, Laboratory biosafety levels. vertebrates and invertebrates safety levels, Biosafety of infectious agents: bacteria, fungus, parasite, prions, viruses, Biosafety of infectious agents: bacteria, fungus, parasite, prions, viruses. Laboratory security and emergency response, guidelines to work with infectious agents and toxins. Regulatory frameworks: FDA, BIS, ISO certification, CDSCO; health & family welfare laws and regulations on design, development, testing and production of biomedical products, including biologics, drugs, biotechnology-derived therapeutics, vaccines and medical devices. Clinical trials and current good manufacturing Practices. Basic introduction to IPR. Post-market issues and requirements.