IVI Online Course

Course Content

Analytical Assay

Immunogenicity Assessment of Vaccines in Clinical Trials 1 Quiz

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Immunogenicity Assessment of Vaccines in Clinical Trials

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Analytical Development

Applications of Analytical Technologies in Process and Product Development for Vaccines 1 Quiz

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Applications of Analytical Technologies in Process and Product Development for Vaccines

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Quality by Design for Vaccines – Role of Process Analytical Technologies (1) 1 Quiz

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Quality by Design for Vaccines – Role of Process Analytical Technologies (1)

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Quality by Design for Vaccines – Role of Process Analytical Technologies (2) 1 Quiz

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Quality by Design for Vaccines – Role of Process Analytical Technologies (2)

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Will New Vaccine Technologies and Improved Analytics Lead to Faster Development and Higher Quality? 1 Quiz

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Will New Vaccine Technologies and Improved Analytics Lead to Faster Development and Higher Quality?

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Biosafety

Biosafety Overview Part 1 1 Quiz

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Biosafety Overview Part 1

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Biosafety Overview Part 2 1 Quiz

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Biosafety Overview Part 2

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Biosafety Program Management 1 Quiz

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Biosafety Program Management

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Clinical

Basic Statistics for Clinical Research 1 Quiz

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Basic Statistics for Clinical Research

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Ethical Consideration in Clinical Development of Vaccines 1 Quiz

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Ethical Consideration in Clinical Development of Vaccines

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GCP Case Study – Common Reasons for Study Failure 1 Quiz

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GCP Case Study – Common Reasons for Study Failure

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ICH-GCP Documentation and Safety Reporting 1 Quiz

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ICH-GCP Documentation and Safety Reporting

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ICH-GCP Responsibilities of Key Stakeholders 1 Quiz

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ICH-GCP Responsibilities of Key stakeholders

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Introduction to Clinical Data Management 1 Quiz

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Introduction to Clinical Data Management

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Introduction to Good Clinical Practice (GCP) 1 Quiz

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Introduction to Good Clinical Practice (GCP)

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Overview of Clinical Trials 1 Quiz

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Overview of Clinical Trials

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Seamless/Adaptive Study Design in Vaccine Development 1 Quiz

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Seamless/Adaptive Study Design in Vaccine Development

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Epidemiology

Epidemiologic Study Designs and Methods in Vaccine Research 1 Quiz

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Epidemiologic study designs and methods in vaccine research

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Epidemiology Activities and Examples of Surveillance Study 1 Quiz

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Epidemiology activities and examples of surveillance study

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The Role of Epidemiology in Supporting Vaccine Development 1 Quiz

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The Role of Epidemiology in Supporting Vaccine Development

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Vaccine Effectiveness Evaluation 1 Quiz

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Vaccine effectiveness study

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Why Disease Burden Matters in Introducing New Vaccines 1 Quiz

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Why Disease Burden Matters in Introducing New Vaccines

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GLP

Introduction to Good Laboratory Practice (GLP) 1 Quiz

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Introduction to Good Laboratory Practice (GLP)

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Toxicology facilities in Support of Biologics Development: Regulatory Requirements, Animal Management and Facility Overview 1 Quiz

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Toxicology facilities in Support of Biologics Development: Regulatory Requirements, Animal Management and Facility Overview

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GMP

Aseptic Processing 1 Quiz

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Aseptic Processing

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Considerations of Raw Material 1 Quiz

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Considerations of Raw Material

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Data Integrity 1 Quiz

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GMP Documentation and Records 1 Quiz

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GMP Documentation and Records

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GMP for Biological Products – Applying the Concepts 1 Quiz

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GMP for Biological Products – applying the concepts

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Holding & Distribution 1 Quiz

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Holding & Distribution

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Important Considerations about Equipment and Utensils for GMP compliance 1 Quiz

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Important Considerations about Equipment and Utensils for GMP Compliance

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Introduction to GMP 1 Quiz

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Introductory to GMP

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Introductory cGMP Part 1 1 Quiz

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Introductory cGMP Part 1

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Introductory cGMP Part 2 1 Quiz

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Introductory cGMP Part 2

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Material Management 1 Quiz

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Material Management

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Organization and Personnel 1 Quiz

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Organization and Personnel

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Personal Hygiene and Contamination Controls 1 Quiz

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Personal Hygiene and Contamination Controls

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Personnel Training and Competency 1 Quiz

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Personnel Training and Competency

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Pest-Control 1 Quiz

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Product Quality Review 1 Quiz

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Product Quality Review

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Raw Material, Ingredients and Storage 1 Quiz

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Raw Material, Ingredients and Storage

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cGMP Requirements for Raw Material & Packaging Material 1 Quiz

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cGMP Requirements for Raw Material & Packaging Material

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Sanitary Facilities and Control Requirements 1 Quiz

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Sanitary Facilities and Control Requirements

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Self-Inspection 1 Quiz

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Self-Inspection

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Statistical Process Control 1 Quiz

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Statistical Process Control

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Training Requirements 1 Quiz

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Training Requirements

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Health Economics

Vaccine Policy and Economic Research 1 Quiz

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Vaccine Policy and Economic Research

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Introductory

An Overview of the History and Types of Vaccines 1 Quiz

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An overview of the history and types of vaccines

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Basic Immunology 1 Quiz

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Basic Immunology

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Types of Vaccines 1 Quiz

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Types of Vaccines

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IP and Tech Transfer

Technology Transfer: An Overview 1 Quiz

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Technology Transfer: An Overview

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Others

UNITAR – Gender Matters

Pharmacovigilance

Introduction to Pharmacovigilance 1 Quiz

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Introduction to Pharmacovigilance

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Pharmacovigilance System in Resource Limited Settings 1 Quiz

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Pharmacovigilance system in resource limited settings

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Post Licensure Vaccine Safety and Value of Post Authorisation Data 1 Quiz

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Post Licensure Vaccine Safety and Value of Post Authorisation Data

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Pre-clinical Development

Establishment of Animal Challenge Model in Vaccine Development 1 Quiz

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Establishment of Animal Challenge Model in Vaccine Development

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Pre-clinical Vaccine Development 1 Quiz

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Pre-clinical Vaccine Development

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Preclinical Development of Conjugate Vaccine 1 Quiz

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Preclinical Development of Conjugate Vaccine

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Process Development

Adjuvants: Roles and Chemical Composition 1 Quiz

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Adjuvant: Roles and chemical composition

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Vaccine Discovery and Development 1 Quiz

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Vaccine Discovery and Development

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Product Development

Integrated Product Development Plan for Vaccines 1 Quiz

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Integrated Product Development Plan for Vaccines

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Target Product Profile 1 Quiz

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Target Product Profile

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Project Management

Introduction of Project Management pt.1 1 Quiz

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Introduction of Project Management

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Introduction of Project Management pt.2

QMS

Continual Improvement 1 Quiz

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Continual Improvement

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Document Control and Standard Operating Procedure (SOP) Development 1 Quiz

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Document Control and Standard Operating Procedure (SOP) Development

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Integration of QRM into Industry and Regulatory Operations 1 Quiz

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QRM as part of Integrated Quality Management

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Introduction to GxP Quality Management Systems (QMS) Part1 1 Quiz

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Introduction to GxP Quality Management Systems (QMS) Part1

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Introduction to GxP Quality Management Systems (QMS) Part2 1 Quiz

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Introduction to GxP Quality Management Systems (QMS) Part2

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Management Commitment & Continual Improvement 1 Quiz

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Management Commitment & Continual Improvement

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QRM Tools and Methodologies 1 Quiz

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QRM Tools and Methodologies

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Risk Management 1 Quiz

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Risk Management

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Regulatory

Regulator’s Perspective When Reviewing the Dossier 1 Quiz

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Regulator’s Perspective When Reviewing the Dossier

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Regulatory Pathways in Vaccine Development 1 Quiz

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Regulatory Pathways in Vaccine Development

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