The ICH Q3D guideline represented a change of paradigm in the control of elemental impurities in medicinal products. In Europe, the guideline is applicable for new or existing marketing authorisations since June 2016 and for authorised medicinal products since December 2017. It is legally binding in the 39 member States of the European Pharmacopoeia since January 2018.
This webinar is intended as a refresher for users, explaining the implementation of ICH Q3D in the texts of the European Pharmacopoeia and the control of elemental impurities in medicinal products using the principles of risk management.
The presentation consists of two parts and will cover the following topics:
Part 1 (30-35 minutes): European Pharmacopoeia
- Implementation of Q3D in the European Pharmacopoeia
- Highlight changes in general and individual monographs
- Harmonisation of general chapter 2.4.20
- The revision of excipient monographs (Phase two)
Part 2 (10-15 minutes): CEP Procedure
- Impact of the Implementation of ICH Q3D in the European Pharmacopoeia
- CEP policy on elemental impurities and examples
Who should attend?
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 domain names 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.