E-Learning course we currently have as a help-out for our participants at the academy is Pharmacovigilance Essentials. This set of modules created by our experts in Dr. Notghi CRO provide information about pharmacovigilance harmonization initiatives and regulatory requirements described in Good Pharmacovigilance Practice (GVP) guidelines released by the European Medicines Agency (EMA). For each major pharmacovigilance process, there is a dedicated guideline. Our program introduces you to the key content of each of the GVP guidelines through a set of 14 web-based training modules.

Module 1

Pharmacovigilance Systems and their Quality Systems

This module explains why a quality system is needed in pharmacovigilance, defines basic terms and principles for quality management in pharmacovigilance, describes the responsibilities of the main actors within the EU pharmacovigilance network, and explains how quality management is generally applied to pharmacovigilance systems.

 

Module 2

The Pharmacovigilance System Master File

The PSMF module explains what a Pharmacovigilance System Master File (PSMF) is, its benefits and who is responsible for preparing and maintaining it. The module outlines what should be captured in the PSMF and describes how the PSMF is supervised by the regulatory network of the EU.

 

Module 3

Pharmacovigilance Inspections

This module explains what pharmacovigilance inspections are and who is inspected, describes the different types of inspections, defines important processes and consequences of PV inspections, and outlines the main roles and responsibilities in the EU.

 

Module 4

Pharmacovigilance Audits

This module explains what audits are, who is audited and why, and describes the main processes in conducting an audit, the reporting requirements and obligations in the EU network.

 

Module 5

Risk Management Systems

The Risk Management System module defines the purpose of risk management in pharmacovigilance, outlines the structure and the main content of a Risk Management Plan (RMP) and describes the main roles and responsibilities in pharmacovigilance risk management.

 

Module 6

Management and Reporting of Adverse Reactions

This module defines the main terminology for reporting adverse reactions, describes the reporting requirements of valid individual case safety reports (ICSRs), and explains how ICSRs of special situations are managed. The module also describes main roles and responsibilities within the reporting chain.

 

Module 7

Periodic Safety Update Report

The PSUR module describes the objectives of the periodic safety update report and the principles for the evaluation of the benefit-risk balance, outlines the format and content of PSURs, and explains the general PSUR procedure and submission rules.

 

Module 8

Post-Authorization Safety Study

This module defines what a PASS is and explains its objectives and principles. It outlines the methods for non-interventional PASS, and describes the requirements, the main roles and responsibilities in conducting a PASS.

 

Module 9

Signal Management

Signal Management explains the roles and responsibilities of the different stakeholders, and outlines the possible actions that follow the detection of a new risk.

 

Module 10

Additional Monitoring

The Additional Monitoring module explains what additional monitoring is and why it is needed, defines key terms, describes criteria for including medicines in the additional monitoring list, and outlines the main roles and responsibilities in the EU network.

 

Module 15

Safety Communication

The Safety communication module explains what safety communication is, its objectives & structure, defines the main forms of safety communication and outlines the roles and responsibilities in coordinating safety announcements in the EU.

 

Module 16

Risk Minimization Measures

This module defines main types of risk minimization measures and it identifies when and why they are needed. It describes main risk minimization steps, outlines main requirements for submission of educational material and main roles and responsibilities in the EU regarding risk minimization measures.

 

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