In this module, you will learn about reference standards used in conjunction with Ph. Eur. monographs and general chapters to ensure the quality of biologicals. It covers the basis of their scientific establishment, provides additional information on their use and address questions that you have as a user. Recent practical examples from both physicochemical and bioassay applications illustrate the session.

Target audience

This training programme is of interest to staff members of national regulatory bodies and scientists involved in the development, manufacturing, quality control, quality assurance and licensing of medicinal products. It is ideal also for new and junior staff members wanting to familiarise themselves with the Ph. Eur. in the field of biologicals.

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Duration: 1 hour, 7 minutes

Programme:

• Ph. Eur. reference standards for biotherapeutics: intended use in physico-chemical tests by Sylvie Jorajuria (00:00 – 29:00)
• Ph. Eur. Biological Reference Preparations (BRPs) for bioassays by Christina Göngrich and Sebastien Jouette (29:00 – 1:07:08)

Download the presentations

• Ph. Eur. Reference standards for biologicals

Other Events/Training Sessions

• Module 1 : Concepts généraux, produits biothérapeutiques et médicaments de thérapie innovante
• Module 2 : Produits dérivés du plasma et vaccins pour usage humain
• Module 4 : Microbiologie