Module 9 2021

For biologicals in particular

• The science and technology of bioassays continues to play a central role in defining product quality and safety

• The principal challenge is the linkage of a quantitative measure of biological activity to the medicinal product function and its potency • It is a speciality within analytical science to which the same principles of design, standardisation, qualification, validation and appropriate use are applied

• Bioassays are also complex, challenging, variable (in the nature of biological systems), and absolutely required

Bioassays Paula Urquhart

The Organisation for Professionals in Regulatory Affairs

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For biologicals in particular

• Vaccine technology is now largely unrecognisable compared to its 18 th 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

Regulation of Vaccines Andrew Deavin

The Organisation for Professionals in Regulatory Affairs

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