- Programme overview
- Did you miss our last webinar on N-nitrosamine impurities?
- Who should attend?
- System requirements
Since the discovery of nitrosamines in sartan medicines, the EDQM and the European Pharmacopoeia (Ph. Eur.) Commission have taken action to address their presence in active pharmaceutical ingredients (APIs). In this webinar, the EDQM will provide users and stakeholders with an update and detailed overview of the approaches for CEPs and the Ph. Eur. strategy with regard to controlling these impurities. There will be a presentation on the recently revised Ph. Eur. monographs for the five sartans with a tetrazole ring, to explain the changes made with a view to helping users in appropriately applying the texts.
With regard to substances covered by CEPs, applicants and CEP holders are requested to include a risk assessment in any new CEP application, sister file or renewal application, as well as in any revision where there is a risk of nitrosamine formation. Furthermore, manufacturers are required to demonstrate that appropriate controls have been established to ensure that these impurities are not present in their active substances.
The speakers will share the EDQM’s expectations with regard to carrying out a risk assessment and identifying appropriate control strategies, as well as the data that should be provided in CEP applications to meet the requirements.
The webinar will take place on 22 April, from 2:30p.m. to 4:00 p.m. (CEST, Paris, France). Participants will also get the opportunity to ask questions live to the speakers.
Topics will include:
- Nitrosamine control in the Ph. Eur.: special focus on recently revised monographs for sartans with a tetrazole ring
- Expectations for the implementation of risk assessment and control strategies for nitrosamines in substances covered by CEPs
- Implementation of revised Ph. Eur. monographs for CEPs for sartan active substances
More information on the EDQM’s response to nitrosamine contamination
Read the latest news on "European Pharmacopoeia: Rapid implementation of the revised sartan monographs on 1 April 2021"
On 21 January 2021, the EDQM held a webinar on "N-nitrosamine impurities: Latest update on the Ph. Eur. approach". If you missed it, don’t worry! The recording is now available on demand.
This webinar will be of interest to all personnel involved in drug development, R&D, pharmaceutical quality assurance and quality control, as well as those working in regulatory affairs.
It will also be of interest to CEP holders and users of CEPs, including competent authorities.
Participation is free of charge.
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.