This training session covers the work and procedures of the European Pharmacopoeia in detail, illustrates the concept of monographs and general chapters for biologicals, and provides some insight into the evolution of thinking and the latest trends in the field.

This training session presents a key opportunity to:

• learn more about the place and role of the EDQM and the Ph. Eur. in the European regulatory framework;
• obtain practical advice on the proper use and interpretation of the Ph. Eur. texts relevant to biologicals (including general considerations on the 3Rs, microbiology chapters and testing for bacterial endotoxins);
• gather information on current hot topics (for example, biotherapeutic products, including monoclonal antibodies and vaccines for human use) and what is expected for the future;
• get an overview of the role and proper use of Ph. Eur. reference standards and of the process used to establish them.

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Target audience

This training course 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 for new and junior staff members wanting to familiarise themselves with the field of biologicals.

Access the video recordings of the presentations

• A guide through individual monographs: case studies using a synthetic peptide and a recombinant DNA protein
• CRS for biologicals, including synthetic peptides
• General chapters supporting individual monographs: host cell proteins, residual DNA, peptide mapping, capillary electrophoresis, glycan analysis, … 
• Individual monographs on biotherapeutics, including monoclonal antibodies: how to address complexity, flexibility of requirements, bioassays; case studies
• RS for biotherapeutics: peptide mapping and glycan mapping

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1. The regulatory framework for medicines in Europe: Place and role of the EDQM and the Ph. Eur. by Susanne Keitel
2. General concepts in the European Pharmacopoeia (Ph. Eur.) by Cathie Vielle
3. Ph. Eur. Reference Standards (RS) for physico-chemical tests by Sylvie Jorajuria
4. Overview of Biologicals Standardisation Programme (BSP) by Catherine Milne
5. Putting Theory into Practice: Microbiology Chapters by Emmanuelle Charton
6. Microbiological assay of antibiotics by Sylvie Jorajuria
7. Pyrogens, monocyte activation test, bacterial endotoxins, recombinant Factor C by Emmanuelle Charton & Gwenaël Cirefice
8. A guide through individual monographs: case studies using a synthetic peptide and a recombinant DNA protein by Olga Kolaj-Robin
9. CRS for biologicals, including synthetic peptides by Sylvie Jorajuria
10. General chapters supporting individual monographs: host cell proteins, residual DNA, peptide mapping, capillary electrophoresis, glycan analysis, by Gwenaël Cirefice, Mihaela Buda & Olga Kolaj-Robin
11. Individual monographs on biotherapeutics by Mihaela Buda
12. Reference Standards for biotherapeutics: peptide mapping and glycan mapping by Sylvie Jorajuria
13. Vaccines for human use: general versus specific requirements, adventitious agents, the 3Rs by Gwenaël Cirefice
14. Advanced therapy medicinal products (ATMPs) by Céline Pugieux-Amarantos, Olga Kolaj-Robin & Emmanuelle Charton
15. How to participate in the Elaboration of the Ph. Eur. by Mihaela Buda
16. Find your way in Pharmeuropa, the Knowledge database & Ph. Eur. Online: Useful hints and other practicalities by Hans-Joachim Bigalke

Other Events / Training Sessions 

• Webinar: Using recombinant factor C for bacterial endotoxin testing in the Ph. Eur.: how far have we come, how far have we to go?