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Certification of Suitability Training Resources

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

6-7 July 2016, Strasbourg, France
European Pharmacopoeia Training session – Chemicals

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.

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