Council for europe portal
Language : en Search
Choose language

Certification of Suitability Training Resources

In line with its commitment to providing clear and timely insight into its work and activities, the EDQM makes the resources of its  training sessions publicly available for the benefit of those stakeholders who could not attend in person.

24-25 May 2018, Zagreb, Croatia

EDQM Training session - Chemicals

NEW : Webinar on Top 10 Deficiencies in CEPs New Applications (recorded on 10 April 2018)
Language : English - Duration : 1 hour

This webinar will present the most frequent questions raised after the initial evaluation of new applications for European Pharmacopoeia Certificates of Suitability (CEP) for chemical purity. It is designed to assist applicants understand and become familiar with CEP application requirements and improve the quality of their dossiers so as to facilitate and avoid delays in the granting of their CEPs. The recording includes a Q&A session after the presentation.

Register for FREE and receive the webinar recording

Webinar on How to get acceptance of CEP Revisions quickly (recorded on 13 November 2017)
Language: English - Duration: 1 hour, 30 minutes

The aim of this webinar is to explain the process to apply for revisions of CEP application files and also how to obtain fast acceptance of the revisions thereby avoiding unnecessary delays.

The presentation will cover the following topics:

- Introduction to the process of revisions

- How to avoid blocking of a request at reception by the EDQM by correctly classifying changes and providing supporting documentation, including a detailed comparative table of the changes.

- Where to include supporting and revised documentation in the submitted file.

Register for FREE and receive the webinar recording

19-20 September 2017, Prague, Czech Republic

The place of the Certification Procedure in the global regulatory environment

Access the presentations (pdf formats)

11-12 July 2017, Strasbourg, France

EDQM  Training session - Chemicals

Webinar on Elemental Impurities (recorded on 16 May 2017)
Language: English                           Duration: 1 hour, 15 minutes

The ICH Q3D guideline represents a change of paradigm in the control of elemental impurities in medicinal products. This webinar will cover how the implementation of ICH Q3D impacts on Ph. Eur. texts and on the assessment of CEP applications. The recording includes a Q&A session after the presentations.

17 October 2016, Strasbourg, France
The Chinese and European Pharmacopoeias – The new editions

Webinar on Electronic Submissions for CEP applications (recorded on 26 May 2016)
Language: English                           Duration: 1 hour

This webinar will cover the EDQM’s eSubmissions Roadmap for CEP Applications with an outline of the major changes to current practices and key deadlines, give detailed instructions on how to prepare and submit CEP applications in electronic format and advice on how to avoid formatting errors. It will also cover Baseline submissions, the EU’s Module 1 Specifications for eCTD (Version 3.0) and the HMA’s CESP.

twitter facebook googleplus pinterest linkedin email