The webinar has been recorded and is available for purchase. Please select the links for pricing and forms.
Nitrosamines and related compounds are a hot topic among regulatory agencies in the U.S., Europe, Canada, Brazil and elsewhere. This effort is being driven by the European Medicines Agency (EMA) asking the Marketing Authorization Holders (MAH) to identify products at risk of N-nitrosamine formation or contamination and to report the outcome by 1 October 2020 (deadline has been extended). In response to enquiries from customers, a template was developed by IPEC.
The webinar provided an overview of the template developed by IPEC-Americas for excipient suppliers to provide to customers in support of their nitrosamine questions. Additionally, an excipient supplier will explain what type of things to consider in development of the supplier comments to the template and an excipient user will provide an overview of how the information can be used to support questions being raised by regulatory authorities.