Course Objectives

On completion of the online course, 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 Delivery

This nine-module self-paced course is presented through voice-annotated lectures, with experts providing insights and real-world implications for each topic. The course includes eight hours of video content, accessible on laptops, tablets, or smartphones. It incorporates interactive features like knowledge checks, quizzes, and a final assessment to ensure participants have grasped and mastered the fundamentals of vaccine regulation. Upon successfully completing the course and assessments, learners will receive a certificate of completion.

Key Highlights

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, Changes & Lot-Release 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.

Target Audience

This programme is designed to cater to a diverse audience within the healthcare industry including physicians, researchers, healthcare and regulatory professionals interested in the regulatory management of vaccines.