GVP

Good Pharmacovigilance Practice Training

This course is prepared for companies and individuals that need to get familiar with the fundamentals of Good Pharmacovigilance Practice. It covers the latest GPvP guidelines, principles and requirements.

Why enroll in this course?

Provides official certificate of achievement
Written by top pharma industry experts and designed by recognized user experience professionals
1 year full access to course materials

About this course

This is a professionally developed and beautifully designed online Good Pharmacovigilance Practice training course (free demo).

It covers EU requirements and standards set by regulatory bodies and provides official certificate of achievement. It is suitable for anyone involved in pharmacovigilance or activities relating to the detection and prevention of medicine-related adverse effects and problems. It is also suitable for all individuals that need official certification in GPvP.

The package contains beautifully designed, interactive presentations that will allow you to enjoy the learning process and easily understand the fundamentals of Good Pharmacovigilance Practice.
Learning objectives

The training aims to help students understand:
- the basic requirements related to pharmacovigilance quality system and system master file;
- how to collect, assess, report and manage ADRs;
- the main principles related to risk management;
- the definition of a signal in pharmacovigilance and how to detect and manage signals;
- the objectives and principles of GPvP inspections and audits;

Pharma Lessons developed a similar course for our company which we implemented in our internal LMS. Pharma Lessons did a fantastic job and we are really happy with the result.
Adeline R.

Great course for beginners as well as working professionals. Covers the fundamentals of pharmacovigilance in a well-organized series of modules. I highly recommend!
Esther Y.

Excellent program! The course content and the final quiz are very well designed and user-friendly. I had great time with this training and learned a lot. Thank you for a great product!
Mubarak A.

Course Syllabus

Chapter 1 Introduction

Definition of Pharmacovigilance
Objectives of Pharmacovigilance
Basic Concepts
- Examples

Chapter 2 Pharmaceutical Quality System

Free demo

Definition of Pharmacovigilance System
Definition of Quality System
Overall Quality Objectives for Pharmacovigilance
Principles of GVP Quality System
Quality Cycle
Responsibilities for the Quality System
Training of Personnel for Pharmacovigilance
Facilities and Equipment
Records Management
Data Protection and Retention
Documentation of the Quality System
Monitoring Performance and Effectiveness
Overall Responsibility of Applicant/MAH
Qualified Person for PV (QPPV)
How to Document QPPV Function
QPPV Authority and Oversight
Quality System Process and Retention Period
Subcontracting

Chapter 3 Pharmacovigilance System Master File

Introduction
Definition
Objectives
Summary of the Applicant’s PV System
PSMF Location
PSMF Registration
Transfers of Responsibilities for the PSMF
Information to be Contained in the PSMF
- Section on QPPV
- Section on Organizational Structure of the MAH
- Section on Source Safety Data
- Section on Computerized Systems & Databases
- Section on PV Processes
- Section on PV System Performance
- Section on Quality System
- PSMF Annexes
PSMF Storage and Retention Periods
Change Control, Logbook, Versions & Archiving
PSMF Accessibility
Responsibilities

Chapter 4 Management and Reporting of ADRs

Collection of Reports
Types of Reports
Solicited reports
Unsolicited reports
- Spontaneous reports
- Literature reports
- Reports from non-medical sources
- Information from the internet
Validation of Reports
Report Assessment
Follow-up of Reports
Special Situations
EU Specific Requirements
Final Reporting Rules
Final Reporting Time Frames and Modalities
EudraVigilance Database
To Be Considered

Chapter 5 Risk Management Systems

Useful Definitions
Risk Identification and Characterization
Principles of Risk Management
Responsibilities of the MAH / Applicant
Objectives of Risk Management Plan
Risk Management Plan Structure
- Preliminary Section of RMP
- Product Overview
- Safety Specification
- Pharmacovigilance Plan
- Plans for Post-Authorization Efficacy Studies
- Risk Minimization Measures
- Summary of the RMP
- Annexes to the RMP
Risk Management Plan Format
When to Submit an RMP
How is the PRAC Involved in the Review of RMPs?
How do the EMA expect to receive the RMP?

Chapter 6 Signal Management

What is a Signal in Pharmacovigilance?
What is Signal Detection?
Where Do Signals Come From?
Signal Management Process
Signal Detection
- Review of ICSRs
- Statistical Analyses in Large Databases
- Combination of statistical methods and review of ICSRs
Signal Validation
Signal Confirmation
Signal Analysis and Prioritisation
Signal Assessment
Recommendation for Action
Exchange of Information

Chapter 7 Pharmacovigilance Inspections

Introduction
Objectives of PV Inspections
Inspection Types
- System and product-related inspections
- Routine and “for cause” PV-inspections
- Pre and Post Authorization Inspections
- Announced and Unannounced Inspections
- Re - Inspections
- Remote Inspections
Inspection Scope
Sites to be Inspected
Inspection Process
Inspection Follow-up
Regulatory Actions and Sanctions
Operation of the EU Network

Chapter 8 Pharmacovigilance Audits

Introduction
Terminology
Pharmacovigilance Audit Objective
Risk-based Approach to PV Audits
Stages of Risk Assessment
Strategic Level Audit Planning
Tactical Level Audit Planning
Operational Level Audit Planning and Reporting
Findings Grading System
Actions Based on Audit Outcomes and Follow-ups
Audits Undertaken by Outsourced Audit Service Providers
Requirements for Audit Reporting in the EU

Certificate

View sample

Ready to get started?