Webinar: ICH guideline on elemental impurities
22 Feb 2017
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is offering a free repeat of its webinar on the implementation of the guideline on elemental impurities.
The International Conference of Harmonisation (ICH) Guideline for Elemental Impurities (Q3D) was adopted by the European Medicines Agency Committee for Human Medicinal Products (EMA/CHMP) in December 2014. It represents a significant change in the control of elemental impurities in medicinal products, moving away from pure substance-based testing towards a holistic control strategy in the finished product.
The Guideline took effect for new marketing authorisation applications in June 2016 and will be applicable for authorised medicinal products from December 2017.
The EDQM webinar will explain how the implementation of the guideline impacts on:
- the texts of the European Pharmacopoeia, including implementation in the general monographs and chapters and impact on individual monographs on substances for pharmaceutical use
- the assessment of applications to obtain a Certificates of Suitability to the monographs of the European Pharmacopoeia (CEP), as described in the document ‘Implementation of ICH Q3D in the Certification Procedure.’ This will include possible scenarios, case studies and the impact on existing CEPs.
It will be hosted by Mr Bruno Spieldenner, Scientific Officer in the European Pharmacopoeia Department and Mr Lennart Seidler, Scientific Officer in the Certification of Substances Department.
The webinar will be held in English and take place at 14:00 CET on 16 May 2017 and will last for 1 hour 15 minutes, including a time for questions. It is aimed at professionals working in pharmaceutical companies in quality control, development, manufacturing and regulatory affairs.