This module begins with a review of the structure of the Ph. Eur., recalling the general underlying concepts, including the General Notices. It covers new and recently revised general chapters and texts that are relevant to biologicals, including those on the Ph. Eur. Commission work programme (such as bacteriophages and mRNA vaccines). In addition, the Ph. Eur. concept of flexibility is presented and illustrated through the recently published chapters on the implementation of pharmacopoeial procedures and comparability of alternative analytical procedures.
The module continues with a session on biotherapeutics where you learn how monographs related to recombinant proteins (including monoclonal antibodies) are developed and how flexibility is built into these texts to address their complexity.
Finally, the module concludes with a session on advanced therapy medicinal products (ATMPs) and how the Ph. Eur. supports the development of this important - and booming - class of products.
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: 2 hours, 46 minutes.
Programme:
- Ph. Eur. General Concepts by Emmanuelle Charton and Mihaela Buda (00:00 – 1:20:29)
- Biotherapeutics by Mihaela Buda (1:20:29 – 2:22:12)
- ATMPs by Olga Kolaj-Robin (2:22:12 – 2:46:21)
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