Mastering Computer Systems In Pharmacovigilance

Maximise Drug Safety With Modern System Management

What you'll learn

Understand the computer Systems Landscape in Drug Safety Domain

End to End process for development of Computer Systems

Maintaining Computer Systems in Pharmacovigilance through it's lifecycle

About Commercial Off The Shelf, SaaS Products and Custom Solutions for Drug Safety

Requirements

Fundamentals of Pharmacovigilance

Description

Pharmacovigilance is the science and practice of monitoring and assessing the safety of pharmaceutical products. It involves the systematic collection, analysis, and evaluation of adverse drug reactions (ADRs) and other relevant safety information. The primary goal of pharmacovigilance is to ensure patient safety by identifying and minimizing risks associated with medications.Pharmacovigilance aims at making the patient and the world safer by keeping an watch over the safety and risk profile of the medicinal products. To implement Pharmacovigilance, there are Pharmacovigilance systems and their quality systems. These pharmacovigilance systems can be implemented through Computer Systems. Hence understanding of the computer systems is important to deliver top quality pharmacovigilance operations.This chapter is all about understanding Computer systems in Pharmacovigilance, the software development approach and the maintenance guidelines. This course will equip you with the required skills to manage computer systems in the Drug safety function.Please note that this training is for educational purpose only. It is not meant to replace any practices at the workplace. Hence, perform due diligence while applying any of the learned concepts at your workplace. Also kindly note that this tutorial does not promise any job opportunities or to get you ready to apply and succeed in job interviews.

Overview

Section 1: Introduction to Compter Systems

Lecture 1 Introduction to the Course and Instructor

Lecture 2 Pharmacovigilance Systems Demystified - The GVP Perspective

Lecture 3 What is a Computer System

Lecture 4 Types of Computer Systems in a Drug Safety Function

Lecture 5 Computer Systems by PV Business Capability

Lecture 6 Computer Systems by Technology Landscape

Section 2: Decision Points for Computer Systems in Pharmacovigilance

Lecture 7 Buy Vs Build Computer Systems - What's Your Preference

Lecture 8 Cloud or On-Premise - Where Will You Host Your Computer System

Lecture 9 System Types - COTS Vs Custom Built

Lecture 10 About Software as a Service Solutions in Pharmacovigilance

Lecture 11 Computer Systems - Products & Platforms Available in the Market

Section 3: Computer System Development

Lecture 12 Initiate New Computer System - Understand the Triggers

Lecture 13 Evaluating Investment - The Business Case for System Design

Lecture 14 The Approval Process for Project Kick-Off

Lecture 15 Approaches to Sofware Development Approaches - Waterfall, Agile and DevOps

Lecture 16 Computer Systems Validation in Drug Safety Domain

Lecture 17 Defining Functional Requirements - For System Design

Lecture 18 Defining Non-Functional Requirements - Part 1

Lecture 19 Defining Non-Functional Requirements - Part 2

Lecture 20 Risk Assessment and Mitigation for New Systems

Lecture 21 How to Perform an Impact Assessment

Lecture 22 Ensure Proper Setup - Installation Qualification

Lecture 23 Verify System Functionality - Operational Qualification

Lecture 24 Assessing User Experience - User Acceptance Testing

Section 4: Computer System Operations and Maintenance

Lecture 25 Incident Management for Drug Safety End Users

Lecture 26 Service Request Management for Drug Safety End Users

Lecture 27 Changes and Release Management for Drug Safety End Users

Lecture 28 Revalidate your Computer Systems - Stay Compliant

Lecture 29 Pharmacovigilance System Retirement and Archival

Lecture 30 Audits and Inspections of a Computer System in Pharmacovigilance

Section 5: Conclusion

Lecture 31 Thank You

Pharmacovigilance Professionals,Healthcare Professionals who work in Drug Safety DOmain,IT Professionals who work in Drug Safety Domain,QA, Compliance and Validation Specialists