Module 9 2024

03/09/2024

Prophylactic Vaccines & Pharmaceuticals: Different Purposes

Vaccines

Pharmaceuticals

Protect Healthy individuals

Treat ‘ sick ’ Patients

The Organisation for Professionals in Regulatory Affairs

15

Why are Vaccines Different? Considerations for registration….

Usually administered to very large numbers of healthy people , often infants, in national immunization programs; thus safety and quality are paramount *

Biological (inherently variable)

• Raw materials may also be biologicals • Biological methods used to test (standardisation difficult) • Range of different technologies used • Often combinations of antigens

The Organisation for Professionals in Regulatory Affairs

16

8

Made with FlippingBook Online newsletter creator