• views: 111
• date: 20 March 2024
• posted by: voska89

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
Homepage
https://www.udemy.com/course/mastering-computer-systems-in-pharmacovigilance/




   
   
   

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