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.
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.
19-20 September 2017, Prague, Czech Republic
The place of the Certification Procedure in the global regulatory environment
Access the presentations (pdf formats)
- New developments of the European Pharmacopeia and their impact on the Certification Procedure by Torbjörn Arvidsson
- The place of the Certification procedure in 2017 in the EU regulatory framework and beyond by Hélène Bruguera
- Experience with CEPs from a European regulatory authority perspective by Blanka Hirschlerová
- Experience with CEPs from the perspective of finished products manufacturers by Helen Robbins
- Experience with CEPs from the perspective of API manufacturers by Marieke Van Dalen
- Experience with CEPs from the perspective of Indian manufacturers by Gopal Joshi
- Experience with CEPs from the perspective of Chinese manufacturers by Hong Xie
- An overview of international initiatives in the regulatory sphere by Cordula Landgraf
- The EU ASMF Work-sharing programme by Nienke Rodenhuis
- The International Generic Drug Regulators’ Programme (IGDRP) initiative by Gary Condran
- International cooperation for inspections of API manufacturers by Monika Mayr
- CEPs: Views from Anvisa, Brazil by Jeanne Sophie Cavalcante Lemos Gautier
- CEPs: Views from South Africa by Mabatane Davis Mahlatji
- CEPs: Views from Canada by Alison Ingham
11-12 July 2017, Strasbourg, France
EDQM Training session - Chemicals
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- General presentation of the Certification Procedure | The Role and Place of the Certification Procedure in the European Regulatory System by Annick Dégardin
- Content of the dossier for a CEP : How to build a successful application by Mr Lennart Seidler
- Revisions of CEPs by Dr Andrew McMath
- The EDQM inspection programme by Dr Sotirios Paraschos
- Use of a CEP by Dr Pascale Poukens Renwart
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
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.