NEW: 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
- The procedure of Certification of Suitability to the Monographs of the European Pharmacopoeia (CEP) and the EDQM Inspection Programme
6-7 July 2016, Strasbourg, France
European Pharmacopoeia Training session – Chemicals
- General presentation of the Certification Procedure | The place of Certification as a regulatory tool : Comparison of CEP and Active Substance Master File by Annick Dégardin
- Content of the dossier for a CEP : How to build a successful application by Dr Cristian Sampaolesi
- Revisions of CEPs by Hélène Bruguera
- The EDQM inspection programme by Dr Sotirios Paraschos
- Use of a CEP by Dr Cristian Sampaolesi
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.