Curriculum Overview
The Regulatory Affairs program at SAGAR INSTITUTE OF PHARMACEUTICAL SCIENCES SAGAR MP is meticulously structured to provide students with a solid foundation in science, ethics, and regulatory compliance. The curriculum spans eight semesters and integrates core disciplines, departmental electives, science electives, and hands-on laboratory experiences.
Course Structure Table
| Semester | Course Code | Course Title | Credit (L-T-P-C) | Pre-requisite |
|---|---|---|---|---|
| I | CHM101 | General Chemistry | 3-0-0-3 | None |
| I | BIO101 | Introduction to Biology | 3-0-0-3 | None |
| I | MAT101 | Mathematics I | 4-0-0-4 | None |
| I | PHYS101 | Physics for Scientists | 3-0-0-3 | None |
| I | ENG101 | English Communication | 2-0-0-2 | None |
| I | CHM102 | Organic Chemistry I | 3-0-0-3 | CHM101 |
| I | BIO102 | Cell Biology | 3-0-0-3 | BIO101 |
| I | MAT102 | Mathematics II | 4-0-0-4 | MAT101 |
| I | LIT101 | Introduction to Pharmacology | 3-0-0-3 | CHM102, BIO102 |
| I | LIT102 | Regulatory Ethics | 2-0-0-2 | None |
| II | CHM201 | Inorganic Chemistry | 3-0-0-3 | CHM102 |
| II | BIO201 | Molecular Biology | 3-0-0-3 | BIO102 |
| II | MAT201 | Statistics and Probability | 3-0-0-3 | MAT102 |
| II | LIT201 | Pharmacokinetics | 3-0-0-3 | LIT101 |
| II | LIT202 | Introduction to Regulatory Affairs I | 3-0-0-3 | LIT101, LIT102 |
| III | BIO301 | Biostatistics | 3-0-0-3 | MAT201 |
| III | CHM301 | Medicinal Chemistry I | 3-0-0-3 | CHM201 |
| III | LIT301 | Clinical Research Practices | 3-0-0-3 | LIT201 |
| III | LIT302 | Good Manufacturing Practices (GMP) | 3-0-0-3 | LIT201 |
| III | LIT303 | Regulatory Writing I | 3-0-0-3 | LIT202 |
| IV | CHM401 | Medicinal Chemistry II | 3-0-0-3 | CHM301 |
| IV | LIT401 | Clinical Trial Regulations | 3-0-0-3 | LIT301 |
| IV | LIT402 | Regulatory Risk Management | 3-0-0-3 | LIT302 |
| IV | LIT403 | Quality Assurance Systems | 3-0-0-3 | LIT302 |
| V | LIT501 | Pharmacovigilance Principles | 3-0-0-3 | LIT401 |
| V | LIT502 | International Regulatory Frameworks | 3-0-0-3 | LIT402 |
| V | LIT503 | Regulatory Strategy for Emerging Therapies | 3-0-0-3 | LIT401 |
| V | LIT504 | Digital Health Regulations | 3-0-0-3 | LIT402 |
| VI | LIT601 | Regulatory Writing II | 3-0-0-3 | LIT503 |
| VI | LIT602 | Regulatory Affairs Capstone Project I | 3-0-0-3 | LIT501, LIT502 |
| VI | LIT603 | Post-Market Surveillance | 3-0-0-3 | LIT501 |
| VII | LIT701 | Regulatory Affairs Capstone Project II | 3-0-0-3 | LIT602 |
| VII | LIT702 | Policy Analysis in Regulatory Affairs | 3-0-0-3 | LIT502 |
| VII | LIT703 | Industry Internship Program | 3-0-0-3 | LIT602 |
| VIII | LIT801 | Final Year Thesis/Capstone Project | 4-0-0-4 | LIT701, LIT702 |
| VIII | LIT802 | Advanced Topics in Regulatory Affairs | 3-0-0-3 | LIT701 |
| VIII | LIT803 | Regulatory Affairs Seminar Series | 2-0-0-2 | LIT702 |
Detailed Course Descriptions
Below are descriptions of several advanced departmental elective courses that form part of the Regulatory Affairs curriculum:
1. Clinical Research Practices
This course provides a comprehensive overview of clinical research methodologies, including study design, data collection, and ethical considerations. Students will learn how to conduct clinical trials in compliance with global standards such as ICH-GCP, Good Clinical Practice guidelines, and FDA regulations.
2. Regulatory Risk Management
Students explore risk assessment frameworks used in regulatory affairs, including hazard identification, impact analysis, and mitigation strategies. The course emphasizes practical applications through case studies from real-world scenarios involving pharmaceutical products.
3. Quality Assurance Systems
This course delves into the principles of quality management systems (QMS) in pharmaceutical environments. Topics include internal audits, corrective and preventive actions (CAPA), and continuous improvement processes aligned with ISO standards and GMP requirements.
4. Pharmacovigilance Principles
This foundational course introduces students to the science of monitoring drug safety post-marketing. It covers adverse event reporting systems, signal detection techniques, and safety database management using industry-standard tools like MedDRA and WHO-UMC.
5. International Regulatory Frameworks
Students examine the regulatory landscapes of major markets including the United States (FDA), European Union (EMA), Japan (PMDA), and other regional bodies. The course includes comparative analysis of approval processes, requirements, and harmonization efforts.
6. Regulatory Strategy for Emerging Therapies
This elective focuses on the unique challenges faced when developing innovative therapies such as gene therapy, cell therapy, and personalized medicine. Students learn how to develop tailored regulatory strategies for these complex products based on their mechanism of action.
7. Digital Health Regulations
With the rapid advancement of digital health technologies, this course addresses regulatory pathways for software-as-a-medical-device (SaMD), wearable diagnostics, and telehealth platforms. It covers topics like cybersecurity standards, validation protocols, and real-world evidence integration.
8. Regulatory Writing I
This course focuses on developing proficiency in writing regulatory documents such as Investigational New Drug (IND) applications, New Drug Applications (NDA), and Marketing Authorization Applications (MAA). Students learn formatting standards, language conventions, and content structure specific to each submission type.
9. Post-Market Surveillance
This course explores how pharmaceutical companies monitor their products after market entry, including adverse event reporting, periodic safety update reports (PSURs), and signal detection methods. Practical case studies are used to illustrate key concepts and best practices.
10. Regulatory Affairs Capstone Project I
This project-based course involves working on a real-world regulatory challenge under faculty supervision. Students select a pharmaceutical product or therapeutic area, research its regulatory pathway, and prepare a detailed submission plan that could be presented to industry professionals.
Project-Based Learning Philosophy
The Regulatory Affairs program at SAGAR INSTITUTE OF PHARMACEUTICAL SCIENCES SAGAR MP embraces project-based learning as a core pedagogical principle. This approach encourages students to apply theoretical knowledge in practical contexts, fostering critical thinking, collaboration, and problem-solving skills essential for success in the field.
Mini-Projects (Semesters III & IV)
During the third and fourth semesters, students engage in mini-projects designed to reinforce concepts learned in core courses. These projects involve conducting literature reviews, analyzing regulatory submissions, or developing compliance strategies for specific product categories. Students work in teams under faculty mentorship and present their findings at a mid-year symposium.
Final-Year Thesis/Capstone Project (Semesters VII & VIII)
The capstone project is the culmination of the program, requiring students to demonstrate mastery in regulatory affairs through an independent research or consulting-style initiative. Projects are selected based on student interests and aligned with current industry needs. Faculty mentors guide students throughout the process, from initial idea development to final presentation.
Project Selection and Mentorship
Students are encouraged to propose project ideas that align with their career aspirations or areas of interest. The Institute maintains a database of potential projects provided by industry partners and faculty members. Each student is assigned a mentor from the faculty or an industry professional, ensuring personalized guidance throughout the project lifecycle.