This module will focus on plasma-derived products, the associated class and individual monographs, and the recent revisions made with a view to continuously improving the quality and safety of these biological products.
Vaccines for human use is the second category of biologicals addressed in this module. Again, you will learn about general versus specific requirements for vaccines (monographs and general chapters supporting vaccines) and time will be devoted to go through pharmacopoeial requirements for adventitious agent testing and what is in the pipeline in this area (including high-throughput sequencing). The 3Rs principles will of course not be forgotten, vaccines being the focus of multiple projects in this sector.
This module will be followed by a live Q&A session.
Programme (subject to change):
- 12:30-13:00 Plasma-derived products
- 13:00-13:45 Vaccines for human use
- 13:45-14:00 Live Q&A