Module 9 2021

23/03/2021

Vaccines are one of the greatest achievements of public health 1

1. MMWR 1999;48:241–243

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Introduction and Structure

Aim of Presentation - Introduce the specific challenges and considerations presented by vaccine manufacturing. Provide a comprehensive guide to the applicable regulations 1. What are vaccines? (including adjuvants and types) 2. Specific Regulatory Considerations for Vaccines

– Technical – Preclinical – Clinical development (safety/efficacy)

3. Specific Processes Used by Vaccines – Article 58 – WHO Prequalification – Control Authority Release System 4. Life Cycle Management of Vaccines 5. Current and Future Opportunities 6. Look at Guidance on Vaccines Around the World 7. Concluding Remarks

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