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Pharmacovigilance

SafetyEasy PV


Description
EXTEDO SafetyEasy™ PV offering is a comprehensive and cost-effective solution designed to streamline pharmacovigilance processes within regulated organizations. It provides the ability to classify, create, review, submit and maintain pharmacovigilance data and adverse event reports within a single, easy-to-use application.

Built specifically to support the E2B(R3) standard, SafetyEasy™ PV handles the reporting and management of all serious and non-serious adverse events. Its future-proof approach is able to generate documentation based around current safety standards and is ready for the arrival of IDMP.

see the EXTEDO website for further details (https://www.extedo.com/products/pharmacovigilance-and-drug-safety/safetyeasy-pv/)
Content
  • SECTION 1: INTRODUCTION AND BACKGROUND
  • About SafetyEasy PV
  • Section 2: Getting Familiar with Safety Easy PV
  • Starting SafetyEasy PV
  • Case View, Navigation and Database Information
  • Test: getting familiar with SafetyEasy PV
  • Safety Easy Story 1: my first case
  • The business scenario
  • Creating a new Case, Identification of the case report
  • Primary Source Information
  • Test: Enter Case Data (1)
  • Reactions and Events
  • Drugs Information
  • Patient Characteristics
  • Test: Enter Case Data (2)
  • Add an Attachment to your case
  • Duplicate Check
  • Use the workflow and the Workflow View
  • Test: Enter Case Data (3)
  • Safety Easy Story 2: completing the first case
  • Contacts and Query Form
  • Drugs Information: Substance Name and Dosage Form
  • MedDRA Coding
  • "Product-Reaction Relatedness"
  • Test: MedDRA Coding
  • Writing the Narrative Case Summary
  • Test: Writing the Narrative Case Summary
  • Case Validation: Exporting E2B files for Troubleshooting
  • Test: Case Validation
  • Other case operations, Promoting cases in the Workflow
  • Safety Easy Story 3: submitting your case
  • Collecting cases for Submission - Calendar and Reporting Matrix
  • Test: Reporting Criteria
  • Submitting a Case via Gateway, Other ways to send a case
  • Test: Submitting a case
  • Safety Easy Story 4: Follow-Up's, Duplicate Cases, Case History
  • Follow-Up’s of Cases
  • Case History
  • Creating a Duplicate of a case
  • Test: Follow-Up's, Duplicates, Case History
  • Safety Easy Story 5: Basic Search and Reporting Features
  • Creating a Printed Report, Reports Engine
  • Using the Reports Engine: Create a New Summary Report
  • Using the Reports Engine: Create a Chart
  • Test: Search and Reporting features
  • Training Feedback
  • Training Evaluation Form
Completion rules
  • You must complete the units "Test: getting familiar with SafetyEasy PV, Test: Enter Case Data (1), Test: Enter Case Data (2), Test: Enter Case Data (3), Test: MedDRA Coding, Test: Writing the Narrative Case Summary, Test: Case Validation, Test: Reporting Criteria, Test: Submitting a case, Test: Follow-Up's, Duplicates, Case History, Test: Search and Reporting features"
  • Leads to a certificate with a duration: 1 year
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