Curriculum | 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 Learning Objectives Teaching Guidelines Methodology 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.

 

Upon completion of this unit the student should be able to explain the process of new drug discovery and development process Concepts of New Drug Discovery and development its stages,development, pre-clinical studies, non-clinical activities, clinical studies, Innovator and generics, Concept of generics, Generic drug product development.

 

 

Attendance, academic activities like quiz, assignments, open book tests, field work, group discussions , seminar ,presentations, student teacher interactions, practical records, & Viva voce 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.

 

Upon completion of this unit the student should be able to explain regulatory approval process Explain regulatory approval process,timelines involve in IND,NDA,ANDA and changes to an approved ndA/ANDA Attendance, academic activities like quiz, assignments, open book tests, field work, group discussions , seminar ,presentations, student teacher interactions, practical records, & Viva voce 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.

 

Upon completion of this unit the student should be able to explain registration of Indian drugs in overseas market Explain registration of Indian drugs 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.

 

Attendance, academic activities like quiz, assignments, open book tests, field work, group discussions , seminar ,presentations, student teacher interactions, practical records, & Viva voce 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

 

Upon completion of this unit the student should be able to explain clinical trials Explain clinical trials,protocols, 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

 

Attendance, academic activities like quiz, assignments, open book tests, field work, group discussions , seminar ,presentations, student teacher interactions, practical records, & Viva voce 8
5 Regulatory Concepts

 

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

 

 

Upon completion of this unit the student should be able to explain regulatory concepts Concept of Regulatory its terminologies, guidance, guidelines, regulations, laws and acts, Orange book, Federal Register, Code of Federal Regulatory, Purple book

 

 

Attendance, academic activities like quiz, assignments, open book tests, field work, group discussions , seminar ,presentations, student teacher interactions, practical records, & Viva voce 7
Admission 2017