Time: 14:00 – 15:00 (CET, Paris)
Duration: about 60 minutes + 15 minutes for questions
The ICH Q3D guideline represents a change of paradigm in the control of elemental impurities in medicinal products. In Europe, the guideline is applicable for new marketing authorisations since June 2016 and will also become applicable to authorised medicinal products within its scope as of December 2017.
Bearing this in mind, the EDQM will host a webinar to explain how the implementation of ICH Q3D impacts the following areas:
- texts of the European Pharmacopoeia,
- the assessment of CEP applications, following the release of the EDQM policy document “Implementation of ICH Q3D in the Certification Procedure” (PA/PH/CEP (16) 23).
The presentation consists of two parts and will cover the following topics:
Part 1 (about 20 min)
- Implementation of the ICH Q3D in the general monographs and chapters
- Impact of the ICH Q3D on individual monographs on substances for pharmaceutical use
Part 2 (about 40 min)
- Overview of the Certification policy: possible scenarios, expectations on content and assessment
- Case studies
- Impact of ICH Q3D and the Ph. Eur. policy on existing CEPs, treatment revisions and renewals
- How to interpret and use the information relating to elemental impurities when mentioned on CEPs
The webinar will be provided by Mr Bruno Spieldenner, Scientific Officer in the European Pharmacopoeia Department and Mr Lennart Seidler, Scientific Officer in the Certification of Substances Department.
Who should attend?
If you missed the first session here is your chance to register for a REPEAT webinar.
Participation is free of charge.
This webinar will be of interest to professionals working in pharmaceutical companies in quality control, development, manufacturing, and regulatory affairs.
No special software is necessary for the webinar. If you wish to connect to audio using VoIP (Voice over Internet Protocol) you will need a fast Internet connection, a microphone and speakers. A USB headset is recommended. The VoIP connection is free. You are strongly advised to consult your IT Department to ensure your computer can receive the webinar and that the following domaine name are neither rejected nor blocked as spam, otherwise you will not receive the link to connect to the webinar: @gotowebinar.com and @care.gotowebinar.com.