As public quality standards, the European Pharmacopoeia (Ph. Eur.) monographs play an essential role in ensuring the quality of medicines and substances for pharmaceutical use.
They are designed to meet the needs of stakeholders, including regulatory authorities (such as OMCLs, assessors) and manufacturers.
The training session will cover the work and procedures of the European Pharmacopoeia in detail, illustrate the concept of monographs and general chapters for biologicals, and provide 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.
Participants will have the opportunity to interact directly with specialists in the field, discuss specific technicalities based on case studies and share practical experience using concrete examples.
Who should attend?