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EDQM Virtual Training Programme: independent modules on Ph. Eur., Reference Standards and CEP Procedure

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2021 Ph. Eur./RS/CEP Training Programme Overview

The training will focus on chemically defined active substances and cover all the fundamentals related to the use of the European Pharmacopoeia 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, policies and practices. Each module will last approximately 1.5 hours and registration is free.
 

Download the programme HERE

 

Training Module Catalogue - On Demand Webinars

 

 

 

Module 1: General Methods, General Chapters & General Monographs (On Demand Webinar)             

Recorded on: 28 June 2021  

Duration: 1 hour, 20 minutes             

About this Module:

This module will open with a walk-through of the structure of the Ph. Eur., opening with a reminder of the general underlying concepts, including the General Notices. The scope and correct use of General Monographs and Dosage Form Monographs as well as 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 recording includes a Q&A session. 

Other Online Resources for Self-Education


Module 2: Individual Monographs - Focus on Chemically Defined Active Substances & Medicinal Products (On Demand Webinar)    

Recorded on: 29 June 2021

Duration: 1 hour, 36 minutes

About this Module:

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 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 recording includes a Q&A session

Module 2 – Register to Watch the Recording  |  Download Presentation slides

Other Online Resources for Self-Education

 


Module 3: Impurity Control in the Ph. Eur. (On Demand Webinar)

Recorded on: 01 July 2021
Duration : 1 hour, 30 minutes
About this Module :
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 they are organic, inorganic (including elemental impurities), solvents or DNA-reactive impurities such as N-nitrosamines.

You will also learn about 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 recording includes a Q&A session. 

Module 3 – Register to Watch the Recording  |  Download Presentation slides


Module 4: Ph. Eur. Reference Standards (RS) (On Demand Webinar)

Recorded on: 02 July 2021    
Duration: 2 hours, 4 minutes

About this Module :

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).

For appropriate application of the quality standards, the links between them need to be understood.

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 recording includes a Q&A session.  

Module 4 – Register to Watch the Recording   
Presentations

Other Online Resources for Self-Education

 


Module 5: Fundamentals of the CEP Procedure (On Demand Webinar)

Recorded on: 05 July 2021
Duration: 1 hour, 30 minutes
About this Module :

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 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.

The recording includes a Q&A session.  

Module 5 – Register to Watch the Recording  
Presentations

 

Module 6: Building successful CEP dossiers (On Demand Webinar)

Recorded on: 06 July 2021                   

Duration: 1 hour, 45 minutes

About this Module :

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 ten 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 to 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.

The recording includes a Q&A session.  

Module 6 – Register to Watch the Recording 
Presentations

 

Module 7: Control of impurities: CEP approach (On Demand Webinar)

Recorded on: 08 July 2021                  
Duration: 1 hour, 30 minutes
About this Module :

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 recording includes a Q&A session.  

Module 7 – Register to Watch the Recording | Download Presentation slides 

 

Module 8: The EDQM Inspection Programme (On Demand Webinar)

Recorded on: 09 July 2021                   

Duration: 1 hour, 37 minutes

About this Module:

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 recording includes a Q&A session.  

Module 8 – Register to Watch the Recording 
Presentations

 


Self-Paced Pre-Training Materials - 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.)
On-demand Webinar
by Pierre Leveau
This video aims to explain the role and responsibilities of the different actors involved in the quality of medicines in Europe. It will also explain the role of the EDQM and the European Pharmacopoeia within the European regulatory system, how they are organised and how they contribute to ensuring the good quality of medicines and their ingredients.
Register to watch the recording (Duration: 30 minutes)
General concepts in the European Pharmacopoeia On-demand Webinar

by Ulrich Rose
This webinar is a walk-through of the structure of the Ph. Eur. It will give some insights into general concepts, including the General Notices. Topics include an explanation of frequently used terms, an outline of the flexibility of the Ph. Eur. with regard to using alternative methods and waiving of tests, and the validation and implementation of Ph. Eur. analytical procedures. Multiple examples are also given to demonstrate how to apply the texts correctly. The scope and correct use of General Monographs and General Chapters will also be explained in this presentation.

Register to watch the recording (Duration: 30 minutes)

How to participate in the Elaboration of the European Pharmacopoeia

On-demand Webinar
by Isabelle Mercier

This short video will explain how to get involved in the work of the Ph. Eur., for example, by proposing a new monograph or requesting the revision of a monograph. It will outline the different procedures (P1 and P4), who to contact, how to submit comments on a draft text as well as how to join the network of Ph. Eur. experts.

Find your way in Pharmeuropa, the Knowledge database & Ph. Eur. Online: Useful hints and other practicalities)

On-demand Webinar
by Chris Jarvis

This talk will give an overview of three of the online resources that are available from the EDQM: the European Pharmacopoeia Online, Pharmeuropa and the Knowledge Database. The speaker will briefly describe the purpose of each resource, present some of their key features and functionalities, and demonstrate where a variety of information can be found.

Ph. Eur. Reference Standards: General Aspects

On-demand Webinar
by Andrea Lodi

Pharmaceutical reference standards (RS) are essential to the quality control of medicinal products and their constituents. This webinar will cover the general aspects of pharmaceutical RS. It will look in particular at the Ph. Eur. RS, which are in fact an integral part of the quality standards of the Ph. Eur. and are therefore essential for the application of the tests described in Ph. Eur. monographs and general chapters. Ph. Eur. RS are needed to identify the pharmaceutical substance or product tested, determine its content or potency and control the impurities that may originate from its manufacturing process. Furthermore, Ph. Eur. RS serve two other important quality control purposes, i.e. verification of system suitability and equipment qualification. Finally, in some specific cases, Ph. Eur. reference standards can also serve to establish in-house secondary standards.

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