M. Sc. (Clinical Research) - Regulatory Affairs

DETAILS

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.

 

Duration of Program

2 years (4 Semesters)

Seats

5

DESIGN YOUR OWN DEGREE


upes

UPES’ curriculum framework is holistic in its overall structure and yet focuses on the individual need of the student to discover, experience, explore and challenge. Along with the core subject, students have the option to choose from subject-focused specialisations. They are also allowed to choose minor/exploratory subject from other schools at UPES that are: School of Engineering, School of Computer Science, School of Law, School of Business, School of Health Sciences, School of Design, School of Modern Media, and School of Liberal Studies.

Further, based on the multifaceted needs of the global workplace and evolving lifestyles, the curriculum offers Signature and Life-Skills courses through School for Life. To round off this learning experience, students are required to do mandatory internships in the social sector, government/public sector, and industry. The combinations available for students to pick and choose from are endless, ensuring both depth and width of knowledge.

  • 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

 

 

Career Prospects
  • 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
Eligibility

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%.

Entrance Test

Personal Interview

Curriculum

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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