NEW: 2024 EDQM virtual training programme: Independent modules on European Pharmacopoeia texts related to Biologicals and on Microbiology chapters
As public quality standards, the European Pharmacopoeia (Ph. Eur.) texts 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 and assessors) and manufacturers.
Dates: 30 January to 1 February 2024
Working Language: English
The training programme will cover the general principles of the Ph. Eur., 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. There will also be a session on microbiology testing, including testing for bacterial endotoxins.
This training programme presents a key opportunity to:
- obtain practical advice on the proper use and interpretation of the Ph. Eur. texts relevant to biologicals; topics covered include biotherapeutics, advanced therapy medicinal products (ATMPs), plasma-derived products and vaccines for human use;
- learn about Ph. Eur. general texts on implementation of pharmacopeial procedures and comparability of alternative procedures;
- understand how texts are developed in order to offer the relevant flexibility necessary to address complex biological products;
- get practical advice on Ph. Eur. general chapters related to microbiology testing, including the test for bacterial endotoxins;
- discover more about the Ph. Eur. pyrogenicity strategy, aimed at phasing out the rabbit pyrogen test by 2025;
- get an overview of the role and correct use of Ph. Eur. reference standards and of the process to establish them.
The EDQM recommends participants watch and read the pre-training materials listed below before joining 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 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 (coming soon)
This training programme will be 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 also for new and junior staff members wanting to familiarise themselves with the Ph. Eur. in the field of biologicals.
All the training modules (webinars) are FREE OF CHARGE.
Places are limited, so sign up today!
Each registered participant will receive a copy of the presentation slides and the link to the webinar recording, which they can refer back to if needed in the future.
The registration link is given under each module.
Participants can register to attend all the modules OR a selection of individual modules.
After registration, you will receive an invitation telling you how to access the webinar and how to test the system beforehand. On the day of the webinar, click on the link in the registration confirmation e-mail.
You can also check your system’s compatibility automatically.
Before registering, please read the Terms of Supply for EDQM Events.
If you have any queries or experience any difficulties registering online, please e-mail us via the EDQM HelpDesk.