Registration of Medicinal Products Based on Monoclonal Antibodies.

Online Course • grapl

About the CPD course

This module addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs); for use in humans. 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 radio labelled mAbs. Finally; we identify the pathways for applications to conduct clinical trials and to market mAb-based products in Europe and the USA.

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grapl

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grapl

grapl is a UK based digital learning and development specialist, authoring and designing Zenosis® courses to provide an extensive eLearning library for the pharmaceutical, biotech and medicinal products sector. This learning can be delivered via the customers LMS, the grapl LMS or its social, knowledge and collaborative CloudRooms platform. Continuously updated to reflect regulatory changes, Zenosis® courses are trusted to educate their people by some of the worlds leading companies.