Objectives
- On completion of this programme, the participants will be able to:
- Highlight key differences between vaccines and conventional therapeutics in lifecycle management processes
- Summarize the efficacy and safety studies in the nonclinical and clinical development of vaccines
- Explain the fundamental principles of vaccine manufacturing and critical attributes for quality evaluation.
- List the regulatory considerations for performing the clinical evaluation for marketing authorization of vaccines
- Identify stakeholder roles and strategies for successful and effective vaccine pharmacovigilance systems
- Discuss pandemic preparedness plans and ensuring equitable vaccine access globally in public health emergencies
Course
Module 1: Introduction to Vaccine Science
This module explores the significance of immunization, the components that trigger immune responses, the characteristics and influencing factors of vaccine protection, various technology platforms, and future challenges in vaccine development.
Module 2: Overview of Vaccine Development
The comprehensive stages involved in vaccine development process are explained, which include lifecycle stages, non-clinical and clinical evaluations, human challenge trials, and ongoing safety monitoring to ensure vaccine effectiveness and reliability.
Module 3: Regulation of Vaccines
Detailing the global regulatory landscape for vaccines, this module delves into lifecycle regulation, detailing essential regulatory features, and World Health Organisation’s (WHO) mechanisms such as prequalification (PQ) and emergency use listing (EUL) that support global access and distribution.
Module 4: Nonclinical Evaluation of Vaccines
This module covers nonclinical evaluation of vaccines, including foundational studies, pharmacological and toxicological assessments, and their inputs to the design of First-In-Human trials.
Module 5: ClinicalEvaluation of Vaccines
Focusing on the clinical testing phase, this module addresses how vaccines are assessed for immune response, effectiveness, and safety, with an emphasis on trial designs and data collected across different phases.
Module 6: Pharmacovigilance for Vaccines
This module focuses on vaccine pharmacovigilance, including post-licensure monitoring, surveillance systems, and vaccine adverse event reporting based on international regulatory guidelines, standards, and best practices.
Module 7: Manufacturing and Lifecycle Management of Vaccines
Insights are provided into the production and purification processes of vaccines, along with international standards for packaging, shipping, lot-release protocols, and lifecycle oversight of manufacturing changes.
Module 8: Quality Evaluation of Vaccines
Outlining the standards and guidelines used to maintain vaccine quality, this module references WHO, International Council for Harmonisation (ICH) guidelines, and US Pharmacopeia (USP) standards, and addresses how manufacturing changes are evaluated in the post-approval phase.
Module 9: Pandemic Preparedness and Access to Vaccines
Exploring strategies for responding to pandemics, this module emphasises the roles of key organizations in vaccine development & production during health emergencies, regulatory approaches for expedited approvals, and frameworks for ensuring equitable access to vaccines.