M PHARM / REGULATORY AFFAIR – THEORY/ I YEAR
| Course outcome number | Course Outcomes | Cognitive level |
| CO1 | To recall the concepts of drug product development, innovator and generic products, their drug master file. | C1 |
| CO2 | To outline the scale up post approval changes, post marketing surveillance and outsourcing of bioavailability studies to CRO. | C2 |
| CO3 | To apply the guidelines of regulatory agencies like USFDA, EU, MHRA, TGA and ROW countries for product approval. | C3 |
| CO4 | To contrast CTD and eCTD format for combination products and medical devices. | C4 |
| CO5 | To compare the submission process of IND, NDA, ANDA and preparation of Medicinal Products Dossier. | C5 |
| CO6 | To build the ability to develop clinical trial protocol, pharmacovigilance and safety monitoring in clinical trials. | C6 |
Remembering (C1) Understanding (C2), Applying (C3), Analyzing (C4), Evaluating (C5) Creating (C6)
