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SUB12: Registration of Medicinal Products Based on Monoclonal Antibodies

SUB12: Registration of Medicinal Products Based on Monoclonal Antibodies

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Highlights

  • On-Demand course

  • 1 hour 30 minutes

  • Intermediate level

Description

This module addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs), for use in humans. Regulatory requirements for the registration of biological medicinal products such as those based on mAbs differ in certain respects from those for small-molecule products. This is because of the distinct characteristics of biologics, such as complex structure and susceptibility to variation during manufacture.

In this module, we focus on distinctive issues in the production and testing of mAbs, in the context of relevant regulatory guidance. We discuss manufacturing quality, nonclinical, and clinical issues. We address aspects specific to radiolabelled mAbs. Finally, we identify the pathways for applications to conduct clinical trials and to market mAb-based products in Europe and the USA.

Course Content

  1. SUB12: Registration of Medicinal Products Based on Monoclonal Antibodies

About The Provider

Zenosis
Zenosis
Dundee
We specialise in Pharmaceutical & Biotech courses for healthcare professionals, as well as a suite of essential courses for regulatory and statutory business compliance. As a member of the CPD, you can be assured that our courses meet exacting standards and deliver a compelli...
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