2023 EDQM virtual training programme: independent modules on the Ph. Eur., reference standards and the CEP Procedure
Date: from 26 June to 7 July 2023
Location: Webinars – Strasbourg, France
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.) and its reference standards, as well as 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.
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.
European regulations for medicines: Place and role of the EDQM and the European Pharmacopoeia (Ph. Eur.) - Duration: 30 minutes
- General concepts in the European Pharmacopoeia - New recording coming soon!
- How to participate in the Elaboration of the European Pharmacopoeia - New recording coming soon!
- Find your way in Pharmeuropa, the Knowledge database & Ph. Eur. Online: Useful hints and other practicalities) - New recording coming soon!
Ph. Eur. Reference Standards: General Aspects Duration: 20 minutes
The Certification procedure: Fact sheet
The list of pre-training materials will also be sent to participants in the registration confirmation e‑mail.
Module 1 General methods, general chapters & general monographs
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, which 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):
10:00-10:05 Technical Introduction
10:05-11:00 General Methods, General Chapters & General Monographs
11:00-11:30 Live Q&A Session
Module 2 Individual monographs – Focus on chemically defined active substances & medicinal products
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 new 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):
10:00-10:05 Technical introduction
10:05-10:35 Individual monographs for chemically defined active substances
10:35-11:00 Individual monographs for medicinal products containing chemically defined active substances
11:00-11:30 Live Q&A Session
Module 3: Impurity control in the Ph. Eur. (live webinar)
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 on 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, specification setting, the correct use of reference standards and the link between individual and general monographs and general chapters and their mandatory or non-mandatory nature. 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):
10:00-10:05 Technical Introduction
10:05-11:00 Impurity control in the Ph. Eur.: theory and practical examples
11:00-11:30 Live Q&A Session
Module 4: Ph. Eur. reference standards (live webinar)
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 a physical standard (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 chemical reference standards used in conjunction with Ph. Eur. monographs and general chapters. It will cover the basis of their scientific establishment, provide additional information on their use and address requirements of GMP inspectors on 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 presentations will be followed by a live Q&A session.
Programme (subject to change):
10:00-10:05 Technical Introduction
10:05-10:45 Ph. Eur. Reference Standards: establishment and use
10:45-10:55 What GMP inspectors expect on RS
10:55-11:45 Handling, dispatch, where to find useful information and other practicalities
11:45-12:10 Live Q&A Session
Module 5: Fundamentals of the CEP Procedure (live webinar)
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 co-existence of CEP 2.0, “hybrid look” CEPs and “old look” CEPs and their respective contents.
The presentation will be followed by a live Q&A session.
This part will also address the co-existence of CEP 2.0, “hybrid look” CEPs and “old look” CEPs and their respective contents.
Programme (subject to change):
10:00-10:05 Technical introduction
10:05-10:35 General overview of the CEP Procedure
10:35-11:15 Use of a CEP
11:15-11:45 Live Q&A session
Module 6: Building successful CEP dossiers (live webinar)
The first part of this module will explain how to build a good application for a new CEP and how to avoid deficiencies. The module will be based on the top 10 most frequently asked questions after the initial evaluation of new CEP applications, along with expectations and recommendations on how to address specific deficiencies with reference to applicable guidelines. It is intended to help applicants improve the quality of their dossiers, in order to facilitate and speed up the granting of a CEP.
The module will also include an introduction to preparing a revision application, provide an explanation of the basic principles for maintaining a CEP, the content of a revision application and the EDQM timelines for assessment. Participants will also be guided through the types of changes with examples and the supporting documentation to be submitted.
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.
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
Programme (subject to change):
10:00-10:05 Technical introduction
10:05-10:35 How to build a good new CEP application
10:35-11:05 Introduction to preparing a revision application
11:05-11:35 Live Q&A session
Module 7: Control of impurities: CEP approach (live webinar)
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):
10:00-10:05 Technical introduction
10:05-11:05 Control of impurities: CEP approach
11:05-11:35 Live Q&A session
Module 8: The EDQM Inspection Programme (live webinar)
This module provides information on how EDQM inspections for API manufacturers are organised, conducted and followed up. The participants will receive information to facilitate efficient preparation for the inspection, in particular with regard to obligations/communications ahead of time. An overview of the nature and distribution of GMP violations observed during EDQM inspections in recent years will also be provided.
The presentation will be followed by a live Q&A session.
Programme (subject to change):
10:00-10:05 Technical introduction
10:05-10:35 Introduction to the EDQM inspection programme
10:35-11:05 How to prepare for an inspection – Most common GMP deficiencies
11:05-11:35 Live Q&A session
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.
