Pharmacovigilance Course

Pharmacovigilance Course

• Pharmacovigilance-Argus safety database 0/23

  • Lecture 1.1
    Clinical Development process
  • Lecture 1.2
    Different phases of Clinical Trials
  • Lecture 1.3
    CRO and Clinical Research Team
  • Lecture 1.4
    Case Report Forms
  • Lecture 1.5
    Data Coding
  • Lecture 1.6
    IB, Protocol and Informed consent form
  • Lecture 1.7
    History and overview of Pharmacovigilance
  • Lecture 1.8
    Regulatory Authorities
  • Lecture 1.9
    Pharmacovigilance in India
  • Lecture 1.10
    Spontaneous reporting
  • Lecture 1.11
    Active pharmacovigilance
  • Lecture 1.12
    Adverse Events and its types
  • Lecture 1.13
    Drug Safety in clinical trials and post marketed drugs
  • Lecture 1.14
    Different sources of Adverse Events reporting
  • Lecture 1.15
    Different types of AE Reporting Forms
  • Lecture 1.16
    Expedited reporting and its timelines
  • Lecture 1.17
    Aggregate reporting
  • Lecture 1.18
    Different departments working on Pharmacovigilance
  • Lecture 1.19
    Four factors for the reportable case
  • Lecture 1.20
    Causality assessment of the adverse event
  • Lecture 1.21
    MedDRA and WHODD coding
  • Lecture 1.22
    SAE narrative writing
  • Lecture 1.23
    PSUR and its submission timelines

• Practical Hands-on Training on Oracle Argus Safety Database Argus Console 0/11

  • Lecture 2.1
    PV Overview
  • Lecture 2.2
    PV Business process
  • Lecture 2.3
    Introduction to Oracle Argus Safety Database
  • Lecture 2.4
    Family, Product and License creation
  • Lecture 2.5
    Clinical Study configuration
  • Lecture 2.6
    Sites, users and Groups creation
  • Lecture 2.7
    Workflow Configuration
  • Lecture 2.8
    Case priority Configuration
  • Lecture 2.9
    Case Numbering
  • Lecture 2.10
    Field Validation
  • Lecture 2.11
    Code list Configuration

• Argus Safety 0/12

  • Lecture 3.1
    Different icons used during the case processing and their purpose.
  • Lecture 3.2
    Different tabs used in case processing
  • Lecture 3.3
    Case Bookin and Data entry
  • Lecture 3.4
    Case Processing
  • Lecture 3.5
    Case Routing Based on workflow
  • Lecture 3.6
    Case Quality check, Medical review
  • Lecture 3.7
    Duplicate case check or verification
  • Lecture 3.8
    Report Generation for Regulatory Submission
  • Lecture 3.9
    Expedited Reports and Aggregate Reports
  • Lecture 3.10
    Case Bookin in LAM and Routing to Central Safety database
  • Lecture 3.11
    MedDRA coding and WHO DD coding
  • Lecture 3.12
    Narrative Writing