|Course: B Pharmacy Year / Semester: 4th / 8th|
|Name of the Subject PHARMACEUTICAL REGULATORY SCIENCE THEORY|
|Subject Code: BP804 ET|
|Sr. No.||Contents of the Topic||Domain||Time (Hrs)|
|1||New Drug Discovery and development
Stages of drug discovery, Drug development process, pre-clinical studies, non-clinical activities, clinical studies, Innovator and generics, Concept of generics, Generic drug product development.
|Desirable to know||10|
|2||Regulatory Approval Process
Approval processes and timelines involved in Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA) in US. Changes to an approved NDA / ANDA.
|3||Registration of Indian drug product in overseas market
Procedure for export of pharmaceutical products, Technical documentation, Drug Master Files (DMF), Common Technical Document (CTD), electronic Common Technical Document (eCTD), ASEAN Common Technical Document (ACTD)research.
|Nice to know||10|
Developing clinical trial protocols, Institutional Review Board / Independent Ethics committee – formation and working procedures, Informed consent process and procedures, GCP obligations of Investigators, sponsors & Monitors, Managing and Monitoring clinical trials, Pharmacovigilance – safety monitoring in clinical trials
Basic terminologies, guidance, guidelines, regulations, laws and acts, Orange book, Federal Register, Code of Federal Regulatory, Purple book
|Desirable to know||7|