Module 9 2024

03/09/2024

The Shifting Landscape

The Organisation for Professionals in Regulatory Affairs

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Vaccines vs. Pharmaceutical - New Modalities Blurring the Lines

Vaccines

Pharmaceutical Products

Generally given prophylactically to people who are well

Generally given as treatments to people who are ill

Prophylactic Mabs

Prophylactic

Therapeutic

Vaccines

Vaccines

Disease

Non Infectious

Infectious Disease

Large study populations available

Small pool of patients

A range of Benefit-Risk ratios across the products – will challenge current regulatory thinking

The Organisation for Professionals in Regulatory Affairs

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