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Global Access Training for Chinese COVID-19 Vaccine Developers

Related program: Center for Vaccine Innovation and Access

China’s substantial vaccine manufacturing capacity has an important role to play for the public good as a global COVID-19 vaccine supplier. This training series supports that effort.

The Global Access Training for Chinese COVID-19 Vaccine Developers developed by PATH provides an overview of key vaccine development strategies and planning necessary to develop COVID-19 vaccines that meet World Health Organization (WHO) prequalification requirements and are competitive in the global market. It is designed to cover high-level perspectives and enhance understanding of prioritized topics specifically focusing on WHO requirements and working with national regulatory authorities outside of China.

The curriculum includes three training modules consisting of a series of courses, each developed by one or more subject matter experts at PATH with experience developing products for WHO prequalification and the global market.

See the fact sheet for a summary of the modules and courses on offer.

Module 1: Planning your route—an overview of vaccine development

  1. Course 1: Design the right product

    A vaccine’s typical development journey from beginning to end, with emphasis on what it takes to enter the global market. Also covered are value proposition and Target Product Profile—and why they’re important when targeting international markets.

  2. Course 2: Designing your regulatory strategy

    Overview of key terms and considerations when building and applying a global regulatory strategy for a vaccine in development.

  3. Course 3: Designing your clinical strategy and plan

    Key elements to take into account when designing and planning a clinical strategy on the vaccine development road to WHO prequalification and the global market.

  4. Course 4: Clinical trial communication and emergency preparedness

    Best practices in vaccine clinical trial communications and crisis communications planning as strategies for delivering clear and accurate messages and sharing vital information that supports vaccine decision-making on the way to global market entry.

  5. Course 5: Aligning regulatory strategy with external stakeholders

    Considerations for identifying and engaging with key regulatory stakeholders, including tips for holding successful meetings with national regulatory authorities.

Module 2: Clinical trial fundamentals

  1. Course 1: Building your foundation: sponsor responsibilities

    Overview of clinical trial standards, the importance of Good Clinical Practice, and clinical trial sponsor roles and responsibilities.

  2. Course 2: Creating successful clinical protocols for international vaccines

    Discussion on clinical trial protocols, the COVID-19 vaccine development journey, considerations for future protocols, and tips for writing protocols for approval.

  3. Course 3: Ensuring study safety

    In-depth discussion on clinical trial safety, including overall responsibilities across Phases 1 through 3, safety recording and monitoring, and accounting for special populations and circumstances.

  4. Course 4: Selecting partners, building effective relationships, and best practices in managing international trial teams

    Key considerations for selecting international study teams, cultivating partner relationship, and working together effectively across borders.

  5. Course 5: Preparation, submission, and maintenance of the Clinical Trial Application (CTA)

    A review of the clinical trial regulatory intelligence process, CTA application considerations, CTA content and format, submission and approval, and lifecycle management from approval to closure.

  6. Course 6: Preparation, conduct, and closeout of global trials

    Preparing for Phase 2 and 3 clinical trials, conducting the study, closing out the study, and best practices and pitfalls.

Module 3: Launching your product and post authorization responsibilities

  1. Course 1: Creating and submitting a Common Technical Document (CTD)

    Considerations for a CTD, including regulatory activities during product development, CTD content and structure, and WHO prequalification process and lifecycle management.

  2. Course 2: Introduction to pharmacovigilance

    The need for pharmacovigilance, what regulators expect, and how to design and document a pharmacovigilance system.

  3. Course 3: Focus on resource requirements for pharmacovigilance

    Overview of pharmacovigilance equipment and facility requirements, how to organize and train staff, and key record management practices.

For users in china

How to access the training in China

Based in China? The trainings can be found on the CNVAC Chinese Vaccinology Course through the University of Chinese Academy of Sciences. For help accessing the training or more information, please email china@path.org.

Visit CNVAC website
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