European Pharmacopoeia Training: Biologicals

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.

 

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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

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