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M.Sc. IN CLINICAL RESEARCH AND REGULATORY AFFAIRS

Duration: 2 years

Eligibility:

Graduate from a recognized University in Health Sciences
(MBBS / BDS / BAMS / BHMS / BUMS / BVSc / BSSM)

OR

Graduate from a recognized University in Allied Health Sciences
[BMLT / BScMLT / BPT / BMIT / BScMIT / BHIA / BScHIA / BOT / BSc (SP & Hg) / BASLP / BSc (Opt) / Pharmacy (B Pharm)]

OR

Graduate from a recognized University in Life Science
(Biotech / Botany / Zoology / Microbiology / Chemistry / Nursing / Home Science / Food and Nutrition)

Methodology: Classes through Projectors, Seminars and Presentation, Industrial Training

Examination: Online Examination, Assignments, & Project work.

Certification: To be awarded by SIKKIM MANIPAL UNIVERSITY

Placement: 100% Job placement support is provided to the Students.

Objective of the course: To provide a comprehensive introduction to the clinical research process. Learn the skills, knowledge and competencies of a candidate for the various job prospects in all aspects of Clinical Research. Become more familiar with roles/jobs as part of the study team.

Course Details:

Sub. Code Subjects Title Semester
MR0001 Fundamentals of clinical operation I Semester
MR0002 Regulatory Affairs-1
MR0003 Clinical Data Management
MR0004 Statistics for Clinical Research
MR0005 Basics of Pharmacy, Drug Discovery & Development
MR0009 IPR & Data Exclusivity, Bioethics in Clinical Research II Semester
MR0010 Regulatory Affairs-II
MR0011 Preclinical Studies safety & Ethics
MR0012 Clinical Data Management
MR0017 Clinical Studies PK, BA, BE studies III Semester
MR0018 Botanicals, Food & Nutraceuticals
MR0019 Clinical Data Management
MR0020 Special Regulatory Process
MR0021 Project: Protocols & Application
MR0025 Project Management & Business Development

 

IV Semester

MR0026 Audit & Inspection
MR0027 Pharmacovigilance & Safety Monitoring
MR0028 Reporting & Medical Writing
MR0029 Internship
MR0032 SAS Certification
 
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