Council for europe portal
Language : en Search
Choose language

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: 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.

twitter facebook googleplus pinterest linkedin email