PGPM + MSc. in Clinical Research and Regulatory Affairs
Post Graduate Diploma
In Mumbai, Navi Mumbai and Aurangabad
Description
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Type
Post Graduate Diploma
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Location
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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
Start date
Start date
Start date
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)
Reviews
Course programme
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
Prinipals of Management and Organizational Behavior
Effecive communications skills
Industry visits
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
Human Resource Management
Managerial economics
Computer skills workshop
Industry visits
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
M.I.S
Business communications workshop
Semester IV:
Project Management & Business Development
Audit & Inspection
Pharmacovigilance & Safety Monitoring
Reporting & Medical Writing
Internship
Applied Medical Transcription VIII
Pharmaceutical Biotechnology
Personality development -workshop
Additional information
PGPM + MSc. in Clinical Research and Regulatory Affairs