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
- Programme
- 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
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