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.
Back by Popular Demand: Untangling the Confusion About What Excipient Suppliers and Users Need to Know About Nitrosamines and Excipients
Cancellation Policy
Note:
Cancellations for live webinars must be made in writing and can be mailed or e-mailed to:
IPEC-Americas Webinars
3138 10th Street N
Arlington, VA 22201
Suite 500
E-mail: ipecamer@ipecamericas.org
Registration fees are refundable for attendees registered for individual webinars, if cancellation is received at least five (5) business days prior to the course. Notices of cancellation received 0-4 business days prior to the course will not be provided a refund. If you registered and are unable to attend the webinar, a recording of the webinar will be provided.
No cancellations are available for webcasts (archived recorded webinars). Recordings are available for 21 days after purchase.
Questions?
Please contact IPEC-Americas Training Coordinator
571-814-3449 or email ipecamer@ipecamericas.org