The aim of this webinar is to explain the context of the elaboration of the European Pharmacopoeia (Ph. Eur.) general chapter Raw materials of biological origin for the production of cell-based and gene therapy medicinal products and its scope. The first part of the webinar gives an introduction to the Ph. Eur. and its place within the EU regulatory network. The second part is dedicated to the general chapter 5.2.12 and provides information on the context of its elaboration, followed by an overview of the chapter and the class of raw materials of biological origin covered.
This webinar will be of interest to professionals working in the quality control, development, and manufacture of biologicals, cell-based and gene therapy medicinal products.
Duration: 1 hour, 30 minutes.
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