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Pharmacovigilance Training  

This course is based on the guideline of Govt and is a complete training solution for all individuals that need to acquire pharmacovigilance knowledge.

Our training can also serve as a refresher course. It is consistent with the legislation changes and is suitable for everyone who needs to be up-to-date with the pharmacovigilance guidelines or is involved in drug safety, pharmacovigilance, regulatory and quality compliance.

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

Upon completion of this course trainees will:

• be able to understand the basics of Good Pharmacovigilance and the current legal regulations and guidelines
• have the confidence to outline the main GVP requirements related to the pharmacovigilance and risk management systems;
• get familiar with the essential documents related to GVP and understand the essence, purpose and structure of important trial related files such as the pharmacovigilance system master file (PSMF), the periodic safety update report (PSUR) and study protocol;

Course Outline

Introduction

• Definition of Pharmacovigilance
• Objectives of Pharmacovigilance
• Legal framework

Pharmacovigilance System And Its Quality Systems

• Pharmacovigilance system and quality systems
• Quality objectives and principles of GVP
• Training of personnel for pharmacovigilance
• Record management and documentation
• Qualified person

Pharmacovigilance System Master File (PSMF)

• Pharmacovigilance System Master File (PSMF)
• Objectives and sections of PSMF
• Annexes to the PSMF
• Change control

Pharmacovigilance Inspections

• Types of Pharmacovigilance inspections
• Inspection follow-up
• Regulatory actions and sanctions

Risk Management Systems

• Principle
• Objectives of Risk Management Plan
• Structure and Content of the Risk Management Plan

Management and Reporting of Adverse Reactions

• Definitions
• Collection of Reports
• Types of Reports
• Validation of Reports
• Time Frames

Periodic Safety Update Report

• Overview
• Format of the Periodic Safety Update Report (PSUR)
• Content of the Periodic Safety Update Report (PSUR)
• Mapping Signals and Risks

Post-Authorisation Safety Studies

• Principles
• Study Protocol
• Format and Content of the Study Protocol