Advanced Diploma in Clinical Research & Regulatory Affairs
About This Course
This program provides dual expertise in clinical research and regulatory affairs, focusing on submissions, approvals, audits, and compliance with global standards.COURSE HIGHLIGHTS 100% Placement Assurance. Outstanding Placement Track Record. Over 3000 students have been suc and pharma industries. Globally Validated Curriculum. Only Institute with In-house CRO facility. Classroom/ Practical...
Show moreWhat you'll learn
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Clinical research & regulatory frameworks
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IND, NDA, ANDA submission process
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CTD/eCTD documentation standards
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GCP, GMP, and GLP compliance
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Handling audits & regulatory inspections
Course Curriculum
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Week 1 – Fundamentals of Clinical Research
read- Phases of trials & regulatory framework
- Introduction to drug development lifecycle
Week 2 – Regulatory Environment
read- Global regulatory agencies (FDA, EMA, MHRA, CDSCO)
- IND, NDA, ANDA pathways
Week 3 – Regulatory Submissions
read- CTD/eCTD format
- Clinical trial applications & approvals
Week 4 – Compliance & Audits
read- GCP, GMP, GLP requirements
- Regulatory audits & inspections
Week 5 – Pharmacovigilance Regulations
read- Safety monitoring & regulatory reporting timelines
- Post-marketing commitments
Week 6 – Final Project & Career Prep
read- Draft a mock regulatory submission
- Interview guidance & placement prep
Prerequisites
M.B.B.S / B.D.S / B.A.M.S / B.H.M.S.
B. Pharmacy / M.Pharmacy / B.M.L.T
BSc in M.L.T / B.P.T / BSc in Nursing.
BSc and MSc in Biotechnology, Microbiology, Genetics
B.E (Biotechnology) / B.tech (Biotechnology).
Biochemistry ,Botany , Zoology ,Statistics or life sciences.
Course Includes:
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1 Topic
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6 Lessons
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6 Articles
