Pharmacovigilance Course
Pharmacovigilance Course
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Pharmacovigilance-Argus safety database 0/23
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Lecture 1.1Clinical Development process
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Lecture 1.2Different phases of Clinical Trials
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Lecture 1.3CRO and Clinical Research Team
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Lecture 1.4Case Report Forms
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Lecture 1.5Data Coding
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Lecture 1.6IB, Protocol and Informed consent form
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Lecture 1.7History and overview of Pharmacovigilance
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Lecture 1.8Regulatory Authorities
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Lecture 1.9Pharmacovigilance in India
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Lecture 1.10Spontaneous reporting
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Lecture 1.11Active pharmacovigilance
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Lecture 1.12Adverse Events and its types
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Lecture 1.13Drug Safety in clinical trials and post marketed drugs
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Lecture 1.14Different sources of Adverse Events reporting
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Lecture 1.15Different types of AE Reporting Forms
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Lecture 1.16Expedited reporting and its timelines
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Lecture 1.17Aggregate reporting
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Lecture 1.18Different departments working on Pharmacovigilance
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Lecture 1.19Four factors for the reportable case
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Lecture 1.20Causality assessment of the adverse event
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Lecture 1.21MedDRA and WHODD coding
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Lecture 1.22SAE narrative writing
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Lecture 1.23PSUR and its submission timelines
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Practical Hands-on Training on Oracle Argus Safety Database Argus Console 0/11
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Lecture 2.1PV Overview
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Lecture 2.2PV Business process
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Lecture 2.3Introduction to Oracle Argus Safety Database
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Lecture 2.4Family, Product and License creation
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Lecture 2.5Clinical Study configuration
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Lecture 2.6Sites, users and Groups creation
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Lecture 2.7Workflow Configuration
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Lecture 2.8Case priority Configuration
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Lecture 2.9Case Numbering
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Lecture 2.10Field Validation
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Lecture 2.11Code list Configuration
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Argus Safety 0/12
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Lecture 3.1Different icons used during the case processing and their purpose.
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Lecture 3.2Different tabs used in case processing
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Lecture 3.3Case Bookin and Data entry
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Lecture 3.4Case Processing
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Lecture 3.5Case Routing Based on workflow
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Lecture 3.6Case Quality check, Medical review
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Lecture 3.7Duplicate case check or verification
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Lecture 3.8Report Generation for Regulatory Submission
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Lecture 3.9Expedited Reports and Aggregate Reports
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Lecture 3.10Case Bookin in LAM and Routing to Central Safety database
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Lecture 3.11MedDRA coding and WHO DD coding
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Lecture 3.12Narrative Writing
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