Training Programs
Pharmacovigilance Training Programs
Structured learning paths for life science professionals, from beginners to advanced practitioners.
Basic Pharmacovigilance
Foundation course covering PV basics, regulatory framework, ADR reporting, and case processing fundamentals.
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Introduction to Pharmacovigilance
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Regulatory framework (CDSCO/WHO)
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ADR identification and reporting
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Basic MedDRA coding
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Advanced Drug Safety
In-depth training on advanced PV concepts, signal detection, aggregate reports, and risk management.
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Signal detection methodologies
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Aggregate safety reporting
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Benefit-risk assessment
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PSUR/PBRER preparation
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Regulatory Reporting
Comprehensive training on ICSR submission, expedited reporting, and regulatory compliance requirements.
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ICSR regulatory requirements
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Expedited vs periodic reporting
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E2B(R3) submission
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Regulatory database submissions
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Signal Detection
Practical training on signal identification, validation, evaluation, and management processes.
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Signal detection methods
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Disproportionality analysis
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Signal validation process
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Signal communication
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Case Processing
Hands-on training in ICSR case processing from intake to database entry and submission.
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Case intake and triage
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Medical coding (MedDRA)
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Narrative writing
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Quality review process
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