M.Sc in Clinical Research and Regulatory Affairs

Master

In Navi Mumbai, Mumbai and Aurangabad

₹ 300,000 + VAT

Description

  • Duration

    2 Years

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.

Facilities

Location

Start date

Aurangabad (Mahārāshtra)
See map
Asian Institute of Health and Science,Gopinath Chamber, 2nd Floor, Adalat Road, Aurangabad, 431005

Start date

On request
Mumbai (Mahārāshtra)
See map
Asian Institute of Health Science,Ravi Hospital, 50, Anandnagar,Vasai (West), 401 202

Start date

On request
Navi Mumbai (Mahārāshtra)
See map
Asian Institute of Health Science,Vaishali Hospital, Sector 10, Plot - 16, Airoli, Navi Mumbai - 400 708, Maharashtra. , 400 708

Start date

On request

About this course

-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, BScMLT, 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)

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Course programme

First Year

Semester I:
Fundamentals of Clinical Operation
Regulatory Affairs - I
Clinical Data Management - I
Statistics for Clinical Research
Basic of Pharmacy, Drug discovery & development
Human Biology -I
Human Biology-II
Basic of Health & Nutrition

Semester II:
IRP & Exclusivity, Bioethics in Clinical Research
Regulatory Affairs - I
Preclinical Studies - I Safety & Efficiency
Clinical Data Management - II
Basic of Molecular Biology & Biotechnology
Basic of Epidemiology
Pharmacology
Basic of Health & Nutrition


Second Year

Semester III:
Preclinicals, Studies -II : PK, BA, BE
Botanicals, Foods & Nutraceuticals
Clinical Data Management -III
Special regulatory Processes
Project : Protocols & Application
Human Genetics
Pharmacogenomics
Case Studies and Seminar

Semester IV:
Project Management & Business Development
Audit & Inspection
Pharmacovigilance & Safety Monitoring
Reporting & Medical Writing
Internship
Applied Medical Transcription VIII
Pharmaceutical Biotechnology





Additional information

Payment options: Rs 75,000 /- per Semester

M.Sc in Clinical Research and Regulatory Affairs

₹ 300,000 + VAT