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.
Ph. Eur. Training Webinar Session 4: Certificate of Suitability (CEP) Procedure (recorded on 8 July 2020)
Language: English Duration: 3 hours, 31 minutes
- Access to the presentations (PDF format)
- General presentation of the CEP procedure its role and working procedures - comparison with the Active Substance Master File (ASMF) procedure in Europe by Annick Dégardin
- How to build a successful CEP application and avoid frequent deficiencies? by Rita Almeida
- Revisions and renewals of CEPs: Principles, frequent changes and sister files by Tiago Gonçalves
- The EDQM Inspection Programme by Dr Thomas Hecker
- Use of a CEP by Pascale Poukens-Renwart
- Register for FREE and receive the webinar recording
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.
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.
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.