Post Graduate Diploma in Clinical Research and Regulatory Affairs

Clinical research and regulatory affairs is a branch of medical
science that determines the safety and effectiveness of
medications, devices, diagnostic products, and treatment
regimens intended for human use. It is also concerned with
investigating the influence of population and biological diversity
as well as disease states on responses to treatment. The results
of clinical research studies (especially clinical trials) are essential
for gaining approval for marketing new medications and
devices or new indications of existing products from regulatory
agencies throughout the world.
India has one of the largest patient populations for most
diseases with genetic diversity. Combined with the large pool of
highly qualified medical practitioners in the country and with
implementation of Good Clinical Practice (GCP) as per the
International Conference on Harmonization (ICH) standards, it
is attracting serious global interest as a site for clinical trials. As
per the recent McKinsey report on clinical trials in India, it is
estimated that the industry potential will grow to $1 billion. This
expectation has created a demand for more clinical research
professionals.
These programs provides necessary training for graduate
students in order to develop diverse careers as Clinical
Research Associates (CRA), Medical Writers, Clinical Data
Coordinators, Drug Development Associates, Business
Development Managers, Clinical Project Manager, Clinical
Research Manager, Regulatory Affairs Manager and
Biostatisticians in Contract Research Organizations (CROs),
pharmaceutical companies, government agencies or
academia.After successful completion of first two semesters of MSc
CRRA, if a student wishes to discontinue, such a student shall
be awarded the Post Graduate Diploma in Clinical Research
and Regulatory Affairs as an exit qualification.
Objectives: This program aims at realizing the following Objectives:
- Provide the students with the requisite knowledge that will
enable them to pursue a career in the Clinical Research
industry
- Give students in-depth training in both the theoretical and
practical aspects of clinical research, regulatory affairs and
clinical data management in the clinical research industry.


First Semester
Sub. Code Title Credits
MR0001 Fundamentals of Clinical Operations 4
MR0002 Regulatory Affairs-I 2
MR0003 Clinical Data Management-I 2
MR0004 Statistics for Clinical Research 2
MR0005 Basics of Pharmacy, Drug discovery &
Development 2
Total credits from compulsory subjects 12
Optional subjects
MR0006 Human Biology-I* 2
MR0007 Human Biology-II* 2
MR0008 Basics of Health & Nutrition* 2
Students have to choose any two subjects
(total of 4 Credits) from optional subjects
Total credits required in Semester 16

Second Semester
Sub. Code Title Credits
MR0009 IPR & Data Exclusivity, Bioethics in Clinical
Research 2
MR0010 Regulatory Affairs-Il 4
MR0033 Preclinical & Clinical Studies 2
MR0012 Clinical Data Management-II 4
Total credits from compulsory subjects 12
Optional subjects
MR0013 Basics of Molecular Biology & Biotechnology# 2
MR0014 Basics of Epidemiology 2
MR0015 Pharmacology* 2
MR0016 Review & Seminar 2
Students have to choose any two
subjects (total of 4 Credits) from optional subjects
Total credits required in Semester 16

Third Semester
Sub. Code Title Credits
MR0034 Pharmaceutical Analysis 2
MR0018 Botanicals, Food & Nutraceuticals 2
MR0019 Clinical Data Management-III 2
MR0020 Special Regulatory Processes 4
MR0021 Project: Protocols & Application 2
Total credits from compulsory subjects 12
Optional subjects
MR0022 Human Genetics* 2
MR0023 Pharmacogenomics 2
MR0024 Case studies and Seminar 2
Students have to choose any two subjects
(total of 4 Credits) from optional subjects
Total credits required in Semester 16

Fourth Semester
Sub. Code Title Credits
MR0025 Project Management & Business Development 2
MR0026 Audit & Inspections 2
MR0027 Pharmacovigilance & Safety Monitoring 2
MR0028 Reporting & Medical Writing 2
MR0029 Internship 4
Total credits from compulsory subjects 12
Optional subjects
MR0030 Applied Medical Transcription* 2
MR0031 Pharmaceutical Biotechnology 2
MR0032 SAS certification # 2
Students have to choose any two subjects
(total of 4 Credits) from optional subjects
Total credits required in Semester 16