Module 9 2024

03/09/2024

Introduction and Structure

3. Opportunities and Future Trends - the Shifting Landscape – Key Success Factors in Enabling Vaccine Access – New Approaches and New Challenges

Introduction to Vaccines

1.

– What are vaccines? (including adjuvants and types) Vaccine Regulation – Specific Regulatory Considerations for Vaccines: Technical; Preclinical; Clinical development (safety/efficacy) – Specific Processes Used by Vaccines – Life Cycle Management of Vaccines

2.

Concluding Remarks

4.

Annex:

5.

– Look at Guidance on Vaccines Around the World – And Further Information on Technical, Non-clinical and Clinical

The Organisation for Professionals in Regulatory Affairs

5

What Are Vaccines?

including adjuvants and vaccine types

The Organisation for Professionals in Regulatory Affairs

6

3