The European Pharmacopoeia (Ph. Eur.) began elaborating monographs on biologicals in the ’70s, starting with vaccines and then moving on to include substances extracted from animal tissues, blood products and biotech products. To continue to meet the needs of users, Ph. Eur. texts must reflect changes not only in the range of medicines available on the market but also in the regulatory framework and guidance (e.g. the concept of biosimilars and the ICH Q8/Q9/Q10 guidelines). The aim of this webinar is to show how the Ph. Eur. embraces these developments, how it has adapted its texts to remain up to date with recent advances in science and medical practice and the challenges that remain ahead.
The presentations cover the following topics:
- Brief introduction to the Ph. Eur.
- How monographs and general chapters are elaborated
- Overview of the main texts dealing with biologicals, with a specific focus on biotech products (role of general chapters, general monographs and specific monographs)
- The flexibility provided by the Ph. Eur., including examples of QbD approaches for biologicals
- The Ph. Eur. and biosimilars, with examples of how their development is being fostered
- Update on the current work programme and hot topics in the field of biotech product monographs
Duration: 1 hour
This webinar is of interest to professionals working on biologicals in national regulatory agencies, regulatory affairs, manufacturing, pharmaceutical or biological analysis as well as in quality control / compliance.
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