This module focuses 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 learn about general versus specific requirements for vaccines (monographs and general chapters supporting vaccines) and time is 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 are of course not forgotten, vaccines being the focus of multiple projects in this sector.
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, 21 minutes
Programme :
- Plasma-derived products by Solène Le Maux (00:00 – 34:01)
- Vaccines for human use by Gwenaël Ciréfice (34:01 – 1:21:12)
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