Module 9 2024

03/09/2024

Regulation of Vaccines – Complex Biologicals

Vaccine technology is now largely unrecognisable compared to its 18th century antecedents, although the underlying mechanisms are no different This has been the longest journey of any product class, and probably the most important one for global public health Regulation of product quality, safety and efficacy is required to take into account the need for rapid availability against an emerging infectious agent strain and for population vaccination programmes Quality, Safety and Efficacy Must be Assured as usually administered to healthy peoples including infants.

The Organisation for Professionals in Regulatory Affairs

79

Regulation of Cell and Gene Therapy Products

Day 3: Lecture 10

With

Sergio Fracchia

The Organisation for Professionals in Regulatory Affairs

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