Advanced Diploma in Clinical Research & Regulatory Affairs
Advanced Diploma in Clinical Research
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
readPhases of trials & regulatory framework Introduction to drug development lifecycle
Week 2 – Regulatory Environment
readGlobal regulatory agencies (FDA, EMA, MHRA, CDSCO) IND, NDA, ANDA pathways
Week 3 – Regulatory Submissions
readCTD/eCTD format Clinical trial applications & approvals
Week 4 – Compliance & Audits
readGCP, GMP, GLP requirements Regulatory audits & inspections
Week 5 – Pharmacovigilance Regulations
readSafety monitoring & regulatory reporting timelines Post-marketing commitments
Week 6 – Final Project & Career Prep
readDraft 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
Sai Chaitanya
Verified
India
Best Career Based Online Training With Labs
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0 Active students
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18 Courses
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Hello! 👋, we are dedicated to delivering academic excellence and professional growth in the fields of Information Technology (IT) and Clinical Research. Our mission is to create a learning environment that blends technical knowledge, research innovation, and industry relevance to prepare learners for global career success.