Pharmacovigilance Training in Oracle Argus Safety with MedDRA & WhoDrug Coding - Hands on Practical Training with Database Access

Pharmacovigilance is pharmacological science relating to detection, assessment and prevention of adverse effects of drugs. Improving drug safety is a task concerning not only regulatory authorities and pharmaceutical industry but also prescribing physicians. This is done right from the drug research and development stage to post marketing drug surveillance. 

This course will provide extensive theoretical & training in Pharmacovigilance. All the topics will be presented by team  of Doctors.  It incorporates end-to-end theoretical & practical training on Pharmacovigilance processes including case assessment practical’s (seriousness of the events, reportablity of case, expectedness of the event) , Data Entry, Case Processing, Medical coding & Narrative Writing.

Following Course Content will be covered during the training:

• General Overview of Pharmacovigilance
• Principles of Signal Detection in Pharmacovigilance
• Communication in Pharmacovigilance
• Post-Marketing Surveillance

 Module 1 – Oracle Argus Safety Overview and Navigation

• Process of Logging in
• User Interface and Navigation
• Functionality of User Interface Elements

 Module 2 – Business Process Workflow

• Pharmacovigilance Business Processes
• Business Workflow
• Processing of a Single Case

 Module 3 – Case Entry and Processing

• Case Management Workflow
• Book in and Case Entry
• Medical and Coding Review
• Printing Medical Summaries
• Closing, Copying and Revising cases

Module 4 – Case Form Features

• Tabs and Fields of a Case Form
• Mangement of Cases using Case Form Fields
• Worklists

Module 5 – Coding Terms and MedDRA browser

• MedDRA Browser
• Encoding Drug Names and Adverse Events
• Medical Dictionaries and Coding

Module 6 – Advanced Conditions

• Role of Advanced Conditions
• Building Complex Queries for retreiving system data.

Module 7 – Dashboards and Utilities

• Overview of Dashboards and Utilities
• Information available on Dashboards
• View, Change or Retrieve Case Information

Module 8 – Reporting and Submissions

• Reporting Capabilities of Argus Safety
• SAE Reconciliation Module
• Study Unblinding Module