DETAILS

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Duration of Program 2 years (4 Semesters)

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Seats 5

Total Seats in M. Sc. (Clinical Research)

Clinical Research enables health care professionals to develop new therapies and diagnostic procedures and medical devices to ensure better patient care. M.Sc. in Clinical Research is a 2-year postgraduate course aimed at providing experiential learning with comprehensive curriculum.

Regulatory Affairs is a domain with a broad overview and the responsibility for collecting all kinds of data from the development processes and sending it to regulatory authorities. The courses will provide broad perspectives and integrated knowledge to the students from Innovation →Discovery → Approval→ Commercialization which implies regulatory affairs are essential to bring the product to the market globally. This course specialization provides a comprehensive education in the important aspects of Regulatory and Quality compliance in pharmaceutical industry. Students gets updated with the current regulatory and compliance issues and explore careers in these exciting times. Nowadays regulations and ever changing laws are driving demand for pharmaceutical regulatory affair professionals who can help companies successfully bring medical products to the market.

In addition this program also offers Artificial Intelligence and Machine Learning (AIML) applications in Clinical Research to upgrade Medical and Health Science. Machine Learning Techniques like pre-trained deep learning models and convolutional neural networks (CNN) provides excellent opportunities for drug-development processes and makes clinical trial more intelligent.

 

Academic Framework

The foundation of higher learning at UPES since its inception has been to explore and promote areas of learning that are innovative and future focused. This has led to constant evolution in facilitating creative and collaborative learning engagements for students through realignment of curriculum and exploration of virtual tools, and open-source courseware; thereby creating borderless learning and access to limitless information.

The new curriculum framework at UPES, ABLE (Academic Blueprint for Learning Excellence) is holistic in its overall structure and yet focuses on the individual need of the student to discover, experience, explore and challenge. The learning is segmented into core subject studies, core specialism studies, minors/exploratory subjects, and signature and life skills learning. The latter three are offered by the newly-instituted School for Life.

SFL (School for Life) is an intrinsic part of the composite UPES student experience and facilitates learning and education that is a balance between what students want, and what is needed of them as future global citizens and leaders of tomorrow. With courses designed to equip students with lifelong learning skills, a focus on a wide range of contemporary issues, and a mandatory social and professional internship experience that is unique, UPES believes in igniting to inspire the best version within an individual to better the world.

  • Clinical Trials Auditor
  • Medical Advisor
  • Programmer- Clinical Research
  • Clinical Research Associate
  • Project Manager- Clinical Research
  • Clinical Research Physician
  • Clinical Research Coordinator
  • Clinical Research Analyst
  • Biostatistician
  • Project Manager- Clinical Research, etc.
  • Scientist
X and XII With 50% and Graduation in any stream such as Life Sciences (Biochemistry, Pharmacology, Toxicology, Biotechnology, Microbiology, Botany or Zoology), M.B.B.S. / B.D.S. / B.A.M.S. / B.H.M.S./B.U.M.S. / BVSc. / B.S.S.M.), Bachelors in Physiotherapy, B. Pharmacy, Nursing with min 50%.
Personal Interview

SEMESTER I

 

Course Code Course Credits Hrs
  Management of Clinical Trials 3 3
  Guidelines, Regulations and Ethics in Clinical Research 3 3
  Pharmacology and Toxicology - I 3 3
  Design of Clinical trials, Conduct, Audit and Compliance  2 2
  Biostatistical Methods in Clinical Research 2 2
  Drug Discovery and Development 2 2
  Biostatistical Methods in Clinical Research Lab 1 2
  Seminar - I 1 1
  Commuication Skill  2 2
  Commuication Skill Lab 1 2
  Research Methodology 1 1
  Disaster Management 2 2
  Open Elective I 3 3
  TOTAL 26 28

 

 

SEMESTER II

 

Course Code Course Credits Hrs
  Perspectives in Clinical Evaluation 2 2
  Good Clinical Practice: Conducting Clinical Trials  2 2
  Pharmacology and Toxicology - II 3 3
  Advanced Epidemiologic and Clinical Research Methods 2 2
  Pharmacovigilance  3 3
  Clinical Research Lab 2 4
  Program Elective - I 3 3
  Seminar - II 1 1
  Artificial Intelligence and Machine Learning in Healthcare 2 2
  Artificial Intelligence and Machine Learning in Healthcare Lab 1 2
  Open Elective - II 3 3
  Summer Internship 0  
       
  TOTAL 24 27

 

  

SEMESTER III

 

Course Code Course Credits Hrs
  Biopharmaceutics and Pharmacokinetics  3 3
  Pharmacotherapeutics   2 2
  Health Economic and Outcome Research (HEOR) 2 2
  Research Project 3 6
  Program Elective - II 2 2
  Program Elective - III 2 2
  Medical writing 2 2
  Seminar - III 1 1
  Intellectual Property Rights and Research Ethics 3 3
  Design Thinking 2 2
  Open Elective - III 3 3
  Summer Internship Presentation and Report 1 1
  TOTAL 26 29

 

  

SEMESTER IV

 

Course Code Course Credits Hrs
  Dissertation work on Regulatory Dossier / Project work 15 30
  Research Seminar 2 2
       
  TOTAL 17 32

 

  

SPECIALIZATION

 

Specialization- Regulatory Affairs   
Quality Control and Quality Assurance in Clinical Trials  PE I
Regulatory Aspects of Clinical Research PE II
Drug Regulation and Registration PE III

 

  

Open Electives

Open Elective- I
Microbial Physiology and Immunology
Pharmaceutical Analysis
Human Physiology
Cell Biology
Open Elective- II
Diet in Disease
Instrumentation in Microbiology 
Structural Biology and Biophysical Chemistry 
Global Perspectives in Toxicology
Open Elective- III
Chromatographic and Spectroscopic Methods
Clinical and Therapeutic Nutrition
Biotechnology
Biopharmaceutics and Pharmacokinetics
Diagnostic Biochemistry 
Molecular Pharmacology and Toxicology

 

 

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