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B.Sc. Clinical Research - REGULATORY AFFAIRS
Program details
The B.Sc. Clinical Research (Regulatory Affairs) program offered by UPES School of Health Sciences & Technology is a comprehensive and specialized course designed to equip students with the necessary knowledge and skills to excel in the field of Regulatory Affairs within the healthcare industry. The program focuses on various critical aspects related to regulatory compliance and product safety. Throughout the course, students will be introduced to the fundamental principles of Regulatory Affairs and its importance in pharmaceuticals, biotechnology, medical devices, and other healthcare sectors. They will learn about the regulations and guidelines set by government agencies that govern the approval and marketing of healthcare products. The program covers topics such as product registration and submission, where students will understand the processes involved in gaining approval for healthcare products.
Moreover, students will delve into regulatory strategy and communication with regulatory agencies, ensuring they are well-prepared to navigate the complex landscape of compliance. They will also gain insights into post-marketing surveillance, which involves monitoring products' safety and efficacy after they have been released to the market. Furthermore, the curriculum of the program includes modules on international regulatory affairs, highlighting the global nature of the healthcare industry and the need for professionals who can handle regulatory matters on an international scale. Quality management systems and regulatory training are also integral parts of the program, emphasizing the significance of maintaining high standards of product quality and ensuring professionals are well-versed in the latest regulatory developments.
In summary, UPES' B.Sc. Clinical Research (Regulatory Affairs) program is tailored to meet the growing demand for qualified regulatory affairs professionals in the healthcare industry. Students will gain a deep understanding of regulatory compliance, product safety, and quality management, making them valuable assets to pharmaceutical, biotechnology, medical device, and other healthcare companies.
Program Highlights
- The B.Sc. Clinical Research (Regulatory Affairs) program at UPES School of Health Sciences & Technology focuses on the critical role Regulatory Affairs plays in ensuring the safety and quality of medical products in the ever-changing healthcare industry.
- The program emphasizes navigating varying regulations and guidelines in different countries, equipping students to handle the complexities of international markets for regulatory approval.
- Students learn to collaborate with research and development teams to ensure products are developed with regulatory requirements in mind, fostering a comprehensive understanding of the healthcare product lifecycle.
- Regular workshops provide valuable insights and strategies to navigate the complex regulatory environment and drive innovation in the healthcare sector.
- Aspiring professionals get hands-on experience acting as a crucial link between pharmaceutical, biotechnology, medical device companies, and regulatory agencies.
- The B.Sc. Clinical Research (Regulatory Affairs) program highlights the pivotal role played by Regulatory Affairs professionals in maintaining the efficacy and quality of medical products, safeguarding public health globally.
Future Scope / Industry Trends
The future scope of the B.Sc. Clinical Research (Regulatory Affairs) program is promising and essential for the pharmaceutical industry. Regulatory Affairs professionals are crucial in ensuring compliance with regulations and ethical standards in drug development. They play a significant role in obtaining approvals for clinical trials and new drug products, as well as monitoring post-marketing activities. Their responsibilities extend to global operations, working with regulatory bodies worldwide for multinational clinical trials and approvals of medical devices and biologics. As the pharmaceutical and healthcare industries continue to grow, the demand for skilled regulatory affairs specialists is expected to increase, making this program an excellent choice for those interested in a dynamic and vital career in clinical research and drug development.
Career Opportunities
Completing the B.Sc. Clinical Research (Regulatory Affairs) program at UPES School of Health Sciences & Technology opens up a plethora of promising career opportunities in the pharmaceutical, biotechnology, and healthcare industries. Graduates are equipped with the essential skills and knowledge to navigate the complex world of regulatory affairs, ensuring compliance with relevant laws and regulations for drug development and clinical trials. Job prospects may include roles such as Regulatory Affairs Specialist, Clinical Research Associate, Drug Safety Associate, or Medical Writer. With the growing demand for professionals who can navigate the regulatory landscape and uphold industry standards, graduates can expect rewarding and fulfilling career paths that contribute significantly to the advancement of medical science and patient welfare.
Placements
The B.Sc. Clinical Research (Regulatory Affairs) program at UPES School of Health Sciences & Technology boasts an outstanding track record of placements, providing students with promising career opportunities in the healthcare industry. Graduates from this program have consistently secured placements in reputable pharmaceutical companies, regulatory agencies, research organizations, and healthcare institutions. The comprehensive curriculum, hands-on training, and industry exposure offered at UPES equip students with the necessary skills and knowledge to excel in the dynamic field of clinical research and regulatory affairs. With strong industry connections and a dedicated placement cell, UPES ensures that its graduates step into the professional world with confidence and competence, making them sought-after professionals in the ever-growing healthcare sector.
Fee Structure
Click here for detailed Fee Structure.
Curriculum
Semester 1
Course | L | T | P | Credit |
---|---|---|---|---|
Human Anatomy and Physiology | 3 | 1 | 2 | 6 |
Fundamentals of Clinical Research | 3 | 1 | 2 | 6 |
Community Health and Disease | 3 | 1 | 2 | 6 |
Ability Enhancement/Co-curricular | 0 | 0 | 0 | 0 |
Living Conversations | 2 | 0 | 0 | 2 |
Environment Sustainability & Climate Change | 2 | 0 | 0 | 2 |
TOTAL | 22 |
Semester 2
Course | L | T | P | Credit |
---|---|---|---|---|
Principles of Biochemistry | 2 | 1 | 1.5 | 4.5 |
Computer Application & Bioinformatics | 2 | 1 | 1.5 | 4.5 |
Fundamentals of Biostatistics | 2 | 1 | 1.5 | 4.5 |
Ability Enhancement/Co-curricular | 0 | 0 | 0 | 0 |
Critical Thinking and Writing | 2 | 0 | 0 | 2 |
Environment Sustainability & Climate Change (Living Lab) | 2 | 0 | 0 | 2 |
Technologies of the Future | 2 | 0 | 0 | 2 |
Elective Course | 2 | 1 | 1.5 | 4.5 |
Biosafety Guidelines | 2 | 1 | 1.5 | 4.5 |
Community Health | 2 | 1 | 1.5 | 4.5 |
Fundamentals of Clinical Research | 2 | 1 | 1.5 | 4.5 |
TOTAL | 24 |
Semester 3
Course | L | T | P | Credit |
---|---|---|---|---|
Pharmacology and Toxicology | 2 | 1 | 1.5 | 4.5 |
Design and Management of Clinical Trials | 2 | 1 | 1.5 | 4.5 |
Clinical Sampling and Analytical Techniques | 2 | 1 | 2 | 5 |
Ability Enhancement/Co- curricular | 0 | 0 | 0 | 0 |
EDGE-Soft Skills | 1 | 0 | 0 | 0 |
Design Thinking | 2 | 2 | 2 | 2 |
TOTAL | 20 |
Semester 4
Course | L | T | P | Credit |
---|---|---|---|---|
Pharmacovigilance | 2 | 1 | 1.5 | 4.5 |
Clinical Pharmacokinetics | 2 | 1 | 1.5 | 4.5 |
Bioethics and Drug Safety | 2 | 1 | 1.5 | 4.5 |
Working with Data | 2 | 2 | 2 | 2 |
Ability Enhancement/Co-curricular | 0 | 0 | 0 | 0 |
EDGE – Advance Communication | 1 | 0 | 0 | 0 |
Elective Course | 2 | 1 | 1.5 | 4.5 |
Clinical Pharmacokinetics | 2 | 1 | 1.5 | 4.5 |
Bioethics and Drug Safety | 2 | 1 | 1.5 | 4.5 |
Regulatory Aspects in Clinical Research | 2 | 1 | 1.5 | 4.5 |
TOTAL | 20 |
Semester 5
Course | L | T | P | Credit |
---|---|---|---|---|
Global Regulations in Clinical Trials | 2 | 1 | 1.5 | 4.5 |
Epidemiology and Global Health | 2 | 1 | 1.5 | 4.5 |
Immunology | 2 | 1 | 1.5 | 4.5 |
Bioinstrumentation | 2 | 1 | 1.5 | 4.5 |
Leadership & Teamwork | 2 | 2 | 2 | 2 |
Ability Enhancement/Co-curricular | 0 | 0 | 0 | 0 |
Industrial Training/Survey/Project | 0 | 0 | 0 | 0 |
TOTAL | 20 |
Semester 6
Course | L | T | P | Credit |
---|---|---|---|---|
Pharmacotherapeutics | 4 | 1 | 1 | 6 |
Biopharmaceutics | 4 | 1 | 1 | 6 |
Data Management Technologies | 4 | 1 | 1 | 6 |
Start your Start-up | 2 | 0 | 0 | 2 |
Ability Enhancement/Co-curricular | 0 | 0 | 0 | 0 |
Industrial Training/Survey/Project | 0 | 0 | 0 | 0 |
TOTAL | 20 |
Semester 7
Course | L | T | P | Credit |
---|---|---|---|---|
Health Economics and Outcome Research | 4 | 1 | 5 | |
Emerging Technologies in Clinical Trials | 3 | 1 | 1 | 5 |
Research Methodology | 3 | 1 | 1 | 5 |
Good laboratory and Manufacturing Practices | 3 | 1 | 1 | 5 |
TOTAL | 20 |
Semester 8
Course | L | T | P | Credit |
---|---|---|---|---|
Industrial Internship/Startup | 0 | 0 | 0 | 15 |
Elective Course | 3 | 2 | 0 | 5 |
Pharmacovigilance | 3 | 2 | 0 | 5 |
Ayush and Lifestyle | 3 | 2 | 0 | 5 |
Site Management Operations | 3 | 2 | 0 | 5 |
TOTAL | 20 |
Eligibility
Interested students must fulfill the minimum eligibility criteria for B.Sc. Clinical Research (Regulatory Affairs) as stated below: Minimum 50% Marks at X & XII with Physics, Chemistry, Biology/ Math’s, and English as a Major Subject in XII.
Selection Criteria
The selection criteria for students interested in enrolling in the B.Sc. Clinical Research (Regulatory Affairs) program offered by UPES School of Health Sciences and Technology depend on the individual's performance in Personal Interview.
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