This module will begin with a review of the structure of the Ph. Eur., recalling the general underlying concepts, including the General Notices. It will cover 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 will be presented and illustrated through the recently published chapters on the implementation of pharmacopoeial procedures and comparability of alternative analytical procedures.
The module will continue with a session on biotherapeutics where you will 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 will conclude 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.
Each session will be followed by a live Q&A session.
Programme (subject to change):
- 13:00-14:30 Ph. Eur. General Concepts & live Q&A
- 14:30-14:45 break
- 14:45-15:45 Biotherapeutics & live Q&A
- 15:45-16:15 ATMPs & live Q&A