India's regulatory framework (NDCT Rules 2019), Ethics Committee submissions, and drug-safety/PV reporting end to end.
one-time · lifetime
Regulatory affairs and pharmacovigilance are where clinical research meets the law and patient safety. This advanced program explains how clinical trials are approved and overseen in India, how Ethics Committees protect participants, and how drug-safety information is collected, assessed and reported throughout a product's life.
You will learn the structure of India's regulatory system (CDSCO and the DCGI), the New Drugs and Clinical Trials Rules 2019, the Ethics Committee submission and approval process, the clinical-trial application pathway, and the full pharmacovigilance cycle — definitions, causality, seriousness, reporting timelines, periodic reports and the Pharmacovigilance Programme of India (PvPI).
It is ideal for CRCs and CRAs moving into regulatory or PV roles, QA staff, and life-science graduates targeting drug-safety and regulatory-affairs careers. Finish the modules and final exam to earn your certificate.
India's Regulatory Landscape, The authorities, the law (NDCT Rules 2019), and how India fits the global picture.
Ethics Committees, The composition, registration and SOPs of an EC, and how a study is reviewed and approved.
Clinical Trial Applications & Approvals, Applying to CDSCO, licences for import and testing, and the rules on consent and compensation.
Pharmacovigilance Foundations, What PV is, the core safety definitions, and how events are assessed for causality and seriousness.
Audits, Inspections & a Culture of Compliance, How regulators inspect, what they commonly find, and how CAPA builds lasting compliance.
The New Drugs and Clinical Trials Rules, 2019
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The global context: ICH, FDA, EMA
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Role and composition of an Ethics Committee
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EC registration and SOPs
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The EC submission and approval process
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The clinical trial application to CDSCO
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Import and test licences
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Consent, compensation and injury
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What is pharmacovigilance?
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ADR, AE, SAE and SUSAR defined
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Causality and seriousness assessment
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SAE reporting timelines in India
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Periodic safety reports (PSUR/DSUR)
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The Pharmacovigilance Programme of India (PvPI)
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Regulatory inspections
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Common findings and observations
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CAPA and a culture of compliance
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6 modules · 18 lessons · Preview lessons are free to read; enroll to unlock the full course.
Clins Research Training Academy
Clins Research Pvt Ltd is a Clinical Research Site Management Organization (SMO) based in Greater Noida. Our courses are designed and delivered by practitioners with hands-on experience across the clinical trial lifecycle.
