Syllabus | PHARMACEUTICAL REGULATORY SCIENCE THEORY | B. Pharmacy

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.

Must  know 10
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
4 Clinical trials

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

Must  know 8
5 Regulatory Concepts

Basic terminologies, guidance, guidelines, regulations, laws and acts, Orange book, Federal Register, Code of Federal Regulatory, Purple book

Desirable to know 7