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IVI Online Course

2023 On-site consultation in Kenya
2023 On-site consultation in Senegal

Course Content

Introductory
Document Control and Standard Operating Procedure (SOP) Development 1 Quiz
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Introduction to GxP Quality Management Systems (QMS) 1 Quiz
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Types of Vaccines 1 Quiz
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Regulatory
Post licensure vaccine safety and Value of post authorisation data 1 Quiz
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Pharmacovigilance system in resource limited settings 1 Quiz
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Regulator’s perspective including inspection when reviewing the dossier 1 Quiz
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Toxicology facilities in Support of Biologics Development: Regulatory Requirements, Animal Management and Facility Overview 1 Quiz
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Development
Adjuvant: Roles and chemical composition 1 Quiz
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An overview of the history and types of vaccines 1 Quiz
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Establishment of Animal Challenge Model 1 Quiz
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Integrated Product Development Plan for Vaccines 1 Quiz
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Pre-clinical Vaccine Development 1 Quiz
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Preclinical development of conjugate vaccine 1 Quiz
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Seamless/adaptive Study Design in Vaccine Development 1 Quiz
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Target Product Profile 1 Quiz
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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 (2) 1 Quiz
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Applications of Analytical Technologies in Process and Product Development for Vaccines 1 Quiz
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Will New Vaccine Technologies and Improved Analytics Lead to Faster Development and Higher Quality? 1 Quiz
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clinical
Basic Statistics for Clinical Research 1 Quiz
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Ethical Consideration for Clinical Development of Vaccines 1 Quiz
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GCP Case Study – Common Reasons for Study Failure 1 Quiz
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ICH-GCP Documentation and Safety Reporting 1 Quiz
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ICH-GCP Responsibilities of Key stakeholders 1 Quiz
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ICH-Organization and GCP Principles 1 Quiz
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Immunogenicity assessment of vaccines in clinical trials 1 Quiz
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Introduction to Clinical Data Management 1 Quiz
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Introduction to Good Clinical Practice (GCP) 1 Quiz
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Vaccine effectiveness study 1 Quiz
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biosafety
Biosafety Overview Part 1 1 Quiz
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Biosafety Overview Part 2 1 Quiz
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Biosafety Program Management 1 Quiz
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GLP
Introduction to Good Laboratory Practice (GLP) 1 Quiz
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gmp
Introduction to GMP 1 Quiz
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Introductory GMP 1 Quiz
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Aseptic Processing 1 Quiz
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Considerations of Raw Material 1 Quiz
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Continual Improvement 1 Quiz
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GMP Documentation and Records 1 Quiz
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GMP for Biological Products – applying the concepts 1 Quiz
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Holding & Distribution 1 Quiz
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Important Considerations about Equipment and Utensils for GMP compliance 1 Quiz
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Introductory cGMP Part 1 1 Quiz
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Introductory cGMP Part 2 1 Quiz
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Management Commitment & Continual Improvement 1 Quiz
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Material Management 1 Quiz
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Personal Hygiene and contamination controls 1 Quiz
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Personnel Training and Competency 1 Quiz
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Pest-Control 1 Quiz
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Principles of QRM & General QRM Process 1 Quiz
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QRM as part of Integrated Quality Management 1 Quiz
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QRM Methods & Tools 1 Quiz
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Raw Material, Ingredients and Storage 1 Quiz
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Sanitary Facilities and Control Requirements 1 Quiz
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Self-Inspection 1 Quiz
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Statistical Process Control 1 Quiz
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Traning Requirements 1 Quiz
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Health Economics and Epidemiology
Epidemiologic study designs and methods in vaccine research 1 Quiz
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Epidemiology activities and examples of surveillance study 1 Quiz
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Health Economics in Decision-making 1 Quiz
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Health economics – field-based evidence generation 1 Quiz
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Health economics – model-based evidence generation 1 Quiz
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The role of epidemiology in supporting vaccine development  1 Quiz
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Why disease burden matters in introducing new vaccines 1 Quiz
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UNITAR – Gender Matters
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