2024 EDQM Virtual Training Programme: 4 independent modules on European Pharmacopoeia texts related to Biologicals and on Microbiology chapters
Module 1: General concepts. Biotherapeutics and ATMPs
This module begins with a review of the structure of the Ph. Eur., recalling the general underlying concepts, including the General Notices. It covers new and recently revised general chapters and texts that are relevant to biologicals ...
Module 2: Plasma-derived products and vaccines for human use
This module focuses on plasma-derived products, the associated class and individual monographs, and the recent revisions made with a view to continuously improving the quality and safety of these biological products.
Module 3: Ph. Eur. Reference standards for biologicals
In this module, you will learn about reference standards used in conjunction with Ph. Eur. monographs and general chapters to ensure the quality of biologicals. It covers the basis of their scientific establishment, provides additional information on their use and address questions that you...
Module 4: Microbiology
In this module, we dive into the Ph. Eur. world of microbiology, starting with the conventional tests such as the test for sterility, the chapters for microbial examination of non-sterile products and the mycoplasma chapter. We then cover the field of rapid microbiological...
Suggested viewing
The EDQM recommends participants watch and read the pre-training materials listed below before watching a training module. The materials will help participants familiarise themselves with some basic concepts and topics which will not be covered in detail in the recorded webinar sessions.
- European regulations for medicines: Place and role of the EDQM and the European Pharmacopoeia (Ph. Eur.)
Duration: 30 minutes - Ph. Eur. Reference Standards: General Aspects
Duration: 20 minutes - Biological Standardisation Programme; an overview
Duration: 26 minutes
