2025 EDQM virtual training programme: independent modules on the Ph. Eur., reference standards and the CEP Procedure
Date: 1 to 12 December 2025
Location: Online
Working language: English
The training programme will focus on chemically defined active substances and medicinal products and cover all the fundamentals related to the use of the European Pharmacopoeia (Ph. Eur.), as well as the updates available in the latest issue. It will also address the use of Ph. Eur. reference standards and the procedure for Certification of suitability to the monographs of the European Pharmacopoeia (CEP).
The programme is divided into a number of different modules, each dealing with a specific subject area or topic. Each module has been designed with your needs in mind, based on feedback collected in post-training surveys. The goal is to provide participants with an in-depth understanding of each topic, the main concepts and related policies and practices. Each module will last approximately 90 minutes and registration is free.
The modules will be of interest to all individuals involved in drug development, R&D, pharmaceutical quality assurance and quality control, as well as those working in regulatory affairs.
They are ideal for anyone looking to build a solid foundation knowledge of both the Ph. Eur. and the CEP Procedure, such as recent graduates or early-career professionals.
The EDQM recommends that participants watch the on-demand webinars and read the document listed below before joining a training module. The materials will help them familiarise themselves with some basic concepts and topics that 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: 27 minutes
- General concepts in the European Pharmacopoeia – Duration: 28 minutes
- How to participate in the elaboration of the European Pharmacopoeia - Duration: 24 minutes
- Ph. Eur. reference standards: general aspects - Duration: 22 minutes
- CEP at a glance
The list of pre-training materials will also be sent to participants in the registration confirmation e‑mail.
Click below to register:
Module 1: General methods, general chapters and general monographs
| Date: 1 December 2025 | Time: 10:00-11:30 (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. The scope and correct use of general monographs, dosage form monographs and general chapters will also be explained. Finally, you will learn about new and revised general chapters and texts, relevant for chemically defined active substances, that have been recently updated or are on the work programme of the Ph. Eur. expert groups.
The presentation will be followed by a live Q&A session.
Programme (subject to change):
- 10:00-11:00 General methods, general chapters and general monographs
- 11:00-11:30 Live Q&A Session
Module 2: Individual monographs – Focus on chemically defined active substances and medicinal products containing them
| Date: 2 December 2025 | Time: 10:00-11:30 (CET, France) |
Individual monographs are the core texts of the Ph. Eur., covering active substances, excipients and also medicinal products. This module will provide an overview of the general principles, the link between individual and general monographs and general chapters, and the structure of monographs on active pharmaceutical ingredients (APIs), excipients and medicinal products containing chemically defined active substances. It will describe the different sections of individual monographs with a focus on the policy for medicinal product monographs (including titles and the dissolution test).
The presentation will be followed by a live Q&A session.
Programme (subject to change):
- 10:00-10:30 Individual monographs on chemically defined active substances
- 10:30-11:00 Individual monographs on medicinal products containing chemically defined active substances
- 11:00-11:30 Live Q&A Session
Module 3: Impurity control in the Ph. Eur.
| Date: 4 December 2025 | Time: 10:00-11:30 (CET, France) |
Impurity control is an essential aspect of quality control in individual monographs of the Ph. Eur. In this module, you will learn about the Ph. Eur. policy for impurity control. It will cover all types of impurities, whether organic, inorganic (including elemental impurities), solvents or DNA-reactive impurities such as N-nitrosamines.
You will also learn about the analytical procedures used, the process of specification setting, the correct use of reference standards and how the different texts of the Ph. Eur. complement each other. In this context, the implementation of the relevant ICH guidelines and their importance for the Ph. Eur. will also be discussed.
The presentation will be followed by a live Q&A session.
Programme (subject to change):
- 10:00-11:00 Impurity control in the Ph. Eur.: theory and practical examples
- 11:00-11:30 Live Q&A Session
Module 4: Ph. Eur. reference standards
| Date: 5 December 2025 | Time: 10:00-12:10 (CET, France) |
The quality standards of the Ph. Eur. are essential for ensuring the quality of all medicines available in Europe and beyond. These standards are usually composed of a documentary standard (monograph or general method) and physical standards (reference standards).
Understanding the links between them is essential for the appropriate application of the Ph. Eur. quality standards.
In this module, you will learn about the chemical reference standards used in conjunction with Ph. Eur. monographs and general chapters. It will cover how they are scientifically established, provide additional information on their use and address requirements of GMP inspectors regarding reference standards. It will also provide practical tips on how best to handle them and points to note when ordering and will address questions that you may have as a user.
The presentation will be followed by a live Q&A session.
Programme (subject to change):
- 10:00-10:40Ph. Eur. Reference Standards: establishment and use
- 10:40-10:50 What GMP inspectors expect concerning RS
- 10:50-11:40 Handling, dispatch, where to find useful information and other practical aspects
- 11:40-12:10 Live Q&A Session
Module 5: Fundamentals of the CEP Procedure
| Date: 8 December 2025 | Time: 10:00-11:45 (CET, France) |
This module will give a general presentation of the CEP Procedure. The background and scope of the CEP Procedure will be explained in detail, and a comparison with the Active Substance Master File (ASMF) procedure will be made. The second part of the module will provide tools and tips on how to read a CEP and understand its content, and give details on how to use it in a marketing authorisation application. This part will also address the recently implemented CEP 2.0.
The presentation will be followed by a live Q&A session.
Programme (subject to change):
- 10:00-10:30General overview of the CEP Procedure
- 10:30-11:15 Use of a CEP
- 11:15-11:45 Live Q&A Session
Module 6: Building successful CEP dossiers: new applications
| Date: 9 December 2025 | Time: 10:00-11:30 (CET, France) |
The first part of this module will explain how to build a good application for a new CEP and avoid deficiencies in order to facilitate and speed up the granting of a CEP.
The module will be based on the recently revised EDQM guideline “Content of the dossier for chemical purity and microbiological quality”, the use of SPOR OMS_IDs for companies and other essential documents such as the QOS template and “top 10 deficiencies”.
This module will also address the preparation of sections 3.2.S.4.1 and 3.2.S.4.2 in line with CEP 2.0.
The presentation will be followed by a live Q&A session.
Programme (subject to change):
- 10:00-11:00 How to build a good new CEP application
- 11:00-11:30 Live Q&A Session
Module 7: Building successful CEP revision applications
| Date: 9 December 2025 | Time: 14:30-16:00 (CET, France) |
The module will include an introduction to the EDQM Guideline for revisions, provide the basic principles for maintaining a CEP and requirements for the content of a revision application, as well as the changes linked to the implementation of CEP 2.0. Participants will also be guided through the types of changes, with examples and information on the supporting documentation to be submitted.
The presentation will be followed by a live Q&A session.
Programme (subject to change):
- 14:30-15:30 How to build a good CEP revision application
- 15:30-16:30 Live Q&A Session
Module 8: Control of impurities: CEP approach
| Date: 11 December 2025 | Time: 10:00-11:30 (CET, France) |
This module will address in detail how to control impurities in active substances in the context of a CEP application. The presentation will outline how to build and justify an appropriate control strategy, not only for organic and mutagenic impurities but also for elemental impurities and organic solvents. Concepts will be illustrated with concrete examples and applicable regulatory requirements will be described.
The presentation will be followed by a live Q&A session.
Programme (subject to change):
- 10:00-11:00 Control of impurities: CEP approach
- 11:00-11:30 Live Q&A Session
Module 9: The EDQM inspection programme
| Date: 12 December 2025 | Time: 10:00-12:00 (CET, France) |
This module provides information on how EDQM inspections for API manufacturers are organised, conducted and followed up. The participants will receive information on the selection of sites by the EDQM, as well as indications on how to prepare efficiently for a GMP inspection, in particular with regard to obligations/communication ahead of time. An overview of the nature and distribution of GMP violations observed during EDQM inspections conducted in recent years will also be provided.
The presentation will be followed by a live Q&A session.
Programme (subject to change):
- 10:00-11:00 Introduction to the EDQM inspection programme
- 11:00-11:30 How to prepare for an inspection – Most common GMP deficiencies
- 11:30-12:00 Live Q&A Session
All the training modules (webinars) are FREE OF CHARGE. Places are limited, so sign up today!
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.
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.
