Registration is now open for the international conference to mark the launch of 11th Edition of the European Pharmacopoeia (Ph. Eur.). The conference will take place from 19 to 21 September 2022, both in-person, in Strasbourg (France), and virtually.
Two dedicated round table discussion are being planned for N-nitrosamines:
Roundtable 3: Potential presence of N-nitrosamines in herbals
Tuesday, 20 September, 11:00-11:40 OR 11:50-12:30
The Committee on Herbal Medicinal Products (HMPC) has published a new “question and answer” document related to the contamination of herbal medicinal products with N-nitrosamines. Data is currently very limited; however, new marketing applications for (traditional) herbal medicinal products should include a risk evaluation in order to prevent and mitigate the presence of N-nitrosamines.
The aim of this roundtable is to collect:
- information on potential reasons for the presence of nitrosamines in herbal medicinal products, herbal preparations and herbal drugs;
- practical cases of risk assessments already performed;
- practical cases of N-nitrosamines detected in herbal medicinal products, herbal preparations and herbal drugs and proposed response measures (risk mitigation, analytical procedures, etc.);
- potential needs with regard to Ph. Eur. texts.
Roundtable 15: DNA reactive impurities: a strategy for individual monographs
Tuesday, 20 September, 16:00-16:40 OR 16:50-17:30
Over the past years, DNA reactive impurities, in particular N-nitrosamines, have been a hot topic for the pharmaceutical industry. The European Pharmacopoeia had set up an implementation approach at the time the ICH M7 guideline was published but owing to the N-nitrosamines issue, the references to the control and testing of DNA reactive impurities in general and individual monographs may need to be refined.
The aim of this roundtable is to:
- give an update on the revision activities for general monographs;
- gather feedback in order to feed into discussions on future strategy.
- discuss the different implementation strategies for individual monographs;