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In this pre-Conference Session you get to know how the requirements of the ICH Q3D Guideline on Elemental Impurities affect the CEP procedure. You will learn
In August 2016, the EDQM released a policy document entitled “Implementation of ICH Q3D in the Certification Procedure” (PA/PH/CEP(16)23). The document describes which data on elemental impurities are required for a new CEP application and for the revision/renewal of an existing CEP. An important part of the document is an Annex 1 providing an example of a risk management summary (RMS). Another important document was published in March 2017 by EMA entitled „Implementation strategy of ICH Q3D guideline“ (EMA/CHMP/QWP/115498/2017). This document addresses specific considerations to enable the practical implementation of ICH Q3D in the EU by providing guidance for Appplicants/MAHs. It applies to new applications, as well as variations to existing authorised medicinal products and also reflects dossier expectations and assessment strategy regarding CEPs and ASMFs.
This pre-Conference Session is designed for all persons involved in the compilation of pharmaceutical dossiers for marketing authorisations in the EU especially the documentation of the drug substance quality in a CEP. Furthermore the Session will be of interest to personnel from Regulatory Affairs, Quality Assurance, Quality Control, Production and Project Management of the pharmaceutical and the API industry.
Elemental Impurities and CEPs – Requirements for new CEP applications, already existing CEPs and CEP revisions
This pre-Conference Session ideally complements the subsequent 20th APIC/CEFIC Conference on Active Pharmaceutical Ingredients.
If you register both for the pre-Conference Session „Elemental Impurities and CEPs – Requirements for new CEP applications, already existing CEPs and CEP revisions“ and the 20th APIC/CEFIC Conference you will benefit from a special rate of 690 EUR (instead of 890 EUR) for the pre-Conference Session!
The ICH Q3D Guideline – an overview