President/Owner/Consultant Black Diamond Regulatory Consulting Lansdale, Pennsylvania
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 to regulators. In response to enquiries from pharmaceutical companies about excipients, a template was developed by IPEC-Americas.
The presentation will provide an overview of the template developed by IPEC-Americas for excipient suppliers to provide to customers in support of their nitrosamine questions. The presentation will explain what type of things to consider in development of the supplier comments to the template and will provide an overview of how the information can be used to support questions being raised by regulatory authorities.
Get an overview of regulatory expectations relative to excipients
Develop an awareness of the various potential sources for nitrosamine formation and/or introduction
Understand how an excipient supplier should complete the template.
Understand how an excipient user can best use information from excipient supplier risk assessments in their identification of products at risk of N-nitrosamine formation or contamination.