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.

Date and location

Dates: 30 January to 1 February 2024

Location: Online

Working Language: English

Programme overview

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.

Preliminary programme

Suggested viewing/reading

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.

Back Module 1: General concepts. Biotherapeutics and ATMPs

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Module 1: General concepts. Biotherapeutics and ATMPs
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ONLINE
Short description

30 JANUARY 2024 - 13:00-16:00 (CET, FRANCE)

This module will open with a walk-through of the structure of the Ph. Eur., recalling the general underlying concepts, including the General Notices. It will cover new and recently revised general chapters and texts that are relevant to biologicals, including those on the Ph. Eur. Commission work programme (such as bacteriophages and mRNA vaccines). In addition, the Ph. Eur. concept of flexibility will be presented and illustrated through the recently published chapters on the implementation of pharmacopoeial procedures and comparability of alternative analytical procedures.

The module will continue with a session on biotherapeutics where you will learn about how monographs related to recombinant proteins (including monoclonal antibodies) are developed and how flexibility is built into these texts to address their complexity.

Finally, the module concludes with a session on Advanced Therapy Medicinal Products (ATMPs) and how the Ph. Eur. supports the development of this important - and booming - class of products.  

Each session will be followed by a Q&A live session.

Programme (subject to change):

  • 13:00-13:05 Technical introduction
  • 13:05-14:30 Ph. Eur. General Concepts & live Q&A
  • 14:30-14:45 break
  • 14:45-15:45 Biotherapeutics & live Q&A
  • 15:45-16:15 Advanced therapy medicinal products (ATMPs) & live Q&A

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Who should attend?

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.

Registration fees

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.

How to register

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. 

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