| Course Name | Regulatory Aspects in Translational Medicine |
| Course Code | 25SCR542 |
| Program | M. Sc. Stem Cell Technology and Regenerative Medicine |
| Semester | 2 |
| Credits | 3 |
| Campus | Kochi |
15 lectures
Medical Devices and Nanomedicine: Introduction; Risk based classification; Product Lifecycle: Design and Development, Biological evaluation (both in vitro and in vivo studies) as per ISO 10993, Phase 1 to Phase 3 clinical Trials; Marketing; Regulators bodies like CDSCO, FDA and EU; Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP)
15 lectures
Quality System Regulations of Medical Devices: ISO 13485; Schedule Y for drugs; Standard Operating Procedures; Validation and Verification Process; Quality Control System; Documentation and Records; Quality Risk Management: ISO 14971
15 lectures
Clinical Investigation of Medical Devices and nanomedicine; New Drug or Device Application and its approval; Good Clinical Practice for Clinical Investigation of medical devices (ISO 14155:2011); Medical Device Rule 2017; Adverse Event Reporting.
Pre-requisites: Basic level biology and chemistry
Total number of classes: 45
Course Outcome
CO1 Product Life cycle and quality considerations of medical devices or
nanomedicine
CO2 Regulatory requirement for approval of medical devices or nanomedicine
CO3 Good Manufacturing Practice Requirement and Quality Assurance
CO4 Clinical investigation of medical devices or nanomedicine
Program Outcomes (PO)
PO1: Bioscience Knowledge
PO2: Problem Analysis
PO3: Design/Development of Solutions
PO4: Conduct Investigations of complex problems
PO5: Modern tools usage
PO6: Bioscientist and Society
PO7: Environment and Sustainability
PO8: Ethics
PO9: Individual & Team work
PO10: Communication
PO11: Project management & Finance
PO12: Lifelong learning
0 – No affinity; 1 – low affinity; 2 – Medium affinity; 3 – High affinity
| C | PO1 | PO2 | PO3 | PO4 | PO5 | PO6 | PO7 | PO8 | PO9 | PO10 | PO11 | PO12 |
| C O | ||||||||||||
| CO 1 | 3 | 2 | 2 | 2 | 2 | 2 | 1 | 2 | – | 1 | 2 | 3 |
| CO 2 | 3 | 2 | – | 2 | – | 3 | 1 | 3 | – | 1 | 2 | 3 |
| CO 3 | 3 | 2 | 2 | 2 | 2 | 2 | – | 3 | – | 1 | 3 | 3 |
| CO 4 | 2 | 3 | 2 | 3 | 2 | 3 | – | 2 | – | 1 | 2 | 3 |
Program Specific Outcomes (PSO)
PSO1. Demonstrate comprehensive knowledge of stem cell biology and their clinical and research relevance.
PSO2. Apply core laboratory techniques for stem cell isolation, characterization, and manipulation.
PSO3. Integrate principles of tissue engineering and biomaterials for regenerative applications.
PSO4. Analyze drug delivery, pharmacokinetics, and bioinformatics relevant to stem cell-based therapies.
PSO5. Evaluate ethical, regulatory, and translational aspects of stem cell product development.
PSO6. Bridge basic science with translational approaches in regenerative medicine and gene therapy.
PSO7. Design and interpret experimental strategies for stem cell-based disease
modeling and preclinical studies.
| – | PSO1 | PSO2 | PSO3 | PSO4 | PSO5 | PSO6 | PSO7 |
| C O | |||||||
| CO 1 | – | – | 1 | – | – | 2 | – |
| CO 2 | – | – | 1 | – | 3 | – | – |
| CO 3 | – | – | 1 | – | 3 | – | – |
| CO 4 | – | 3 | 1 | – | – | – | – |
Evaluation Pattern: 50+50 = 100
| Internal Assessment – 50% | ||
| Periodical 1 | Exam | 20% |
| Periodical 2 | Exam | 20% |
| Continuous Assessment | Assignment/Test/Quiz | 10% |
| 50% | ||
| End Semester Examination- 50% | ||
| Theory Exam | 50% | |
| 50% | ||
| Total | 100% | |
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