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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.


NEW : Webinar on ‘How to read a CEP’ (recorded 29 November 2018)
Language : English  Duration : 1 hour.

The webinar will present the EDQM’s guideline “How to read a CEP”. It is designed to clarify and improve holders’ and users’ understanding of the content of Certificates of suitability to the European Pharmacopoeia.  The presentation will cover the aim and scope of a CEP, how to interpret the information laid down in each type of CEP and the update of CEPs after revisions and renewals.

>> Register for FREE and received the webinar recording


Webinar on the newly revised EDQM Guideline on requirements for revision/renewal of Certificates of Suitability’  (recorded on 26 September 2018)
Language : English  Duration : 1 hour

This webinar will present the changes in the acceptability and classification of some revisions described in the newly revised EDQM ‘Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia monographs. It will also cover the revision process, the recent changes in acceptability and classification of some revisions, where to include supporting and revised documentation in the submitted file and good practices to help certificate holders gain rapid acceptance of their proposed changes.

>> Register for free and receive the webinar recording


24-25 May 2018, Zagreb, Croatia

EDQM Training session - Chemicals


 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


 

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.

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