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     POST GRADUATE

 

MBA in Health Care Science

 

MSc in Bioinformatics

     GRADUATE

 

BSc.MIT

 

DMIT

 

BSc.MLT

 

DMLT

 

BSc.HIA

 

DHIA

 

 

 

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M.Sc. CRRA - M.Sc. in Clinical Research & Regulatory Affairs

 

This program aims at providing the students with the requisite knowledge that will enable them to pursue a career in the Clinical Research Industry.


This program also aims at giving in-depth training to students in both theoretical & practical aspects of Clinical Research, Regulatory Affairs & Clinical Data Management in the Clinical Research Industry.

 

 

M.Sc. CRRA

 

 

Course Details for M.Sc. CRRA

 

Eligibility:

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

 

(OR)

 

Graduate from recognized University in Allied Health Sciences. BMLT, B.Sc. MLT, BPT,BScMIT,BHIA,BScHIA,,BSc(Sp&Hg),BASLB,BScOPT,PHARMACY(B.Pharm)

 

(OR)

 

Graduate from recognized University in Life Science (Bio-Tech, Botany,Zoology,Microbiology,Chemistry,Nursing,Home Science,Food & Nutrition).

Duration:

2 years (4 semesters)

Documents Required:

Attested Xerox copies of 10th 12th pass, graduation & mark sheets of all courses, 3 photographs.

Fees:

Rs.26,100 per semester (University fee -Weekend batch)

The fee is inclusive of –


• Study materials & Exam fees.
• Placement assistance to be provided to all students.

 

Hostel Facility:

Boarding & Lodging facilities available on request.

 

 

 

Course Content for M.Sc. CRRA

Fisrt Year

Semester I

Semester II

Fundamentals of Clinical Operation

IRP & Exclusivity, Bioethics in Clinical Research

Regulatory Affairs - I

Regulatory Affairs - II

Clinical Data Management – I

Preclinical & Clinical Studies

Statistics for Clinical Research

Clinical Data Management - II

Basic of Pharmacy, Drug discovery & development

 

Optional Subjects (Any Two)

Optional Subjects (Any Two)

Human Biology -I

Basic of Molecular Biology & Biotechnology

Human Biology -II

Basic of Epidemiology

Basic of Health & Nutrition

Pharmacology

 

Review & Seminar

 

Industry visits

 

Second Year

Semester III

Semester IV

Pharmaceutical Analysis

Project Management & Business Development

Botanicals, Foods & Nutraceuticals

Audit & Inspections

Clinical Data Management –III

Pharmacovigilance & Safety Monitoring

Special regulatory Processes

Reporting & Medical Writing

Project : Protocols & Application

Internship

Optional Subjects (Any Two)

Optional Subjects (Any Two)

Human Genetics

Applied Medical Transcription

Pharmacogenomics

Pharmaceutical Biotechnology

Case Studies and Seminar

SAS Certification

 

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