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.
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.