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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.
Learning objectives for this webinar include:
1. Overview of regulatory expectations relative to excipients
2. Awareness of the various potential sources for nitrosamine formation and/or introduction
3. Understanding how an excipient supplier should complete the template.
4. Understanding 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.
Priscilla Zawislak – IPEC-Americas Immediate Past-Chair; Vice President, IPEC Federation; Global Regulatory Affairs Advocacy Manager for Dupont Nutrition and Biosciences.
Ms. Priscilla Zawislak has over 35 years’ experience in regulatory affairs and quality for excipients, food additives and ingredients for personal care products. She is IPEC-Americas Immediate Past-Chair and is the current Vice President of the IPEC Federation. Priscilla is the Global Regulatory Affairs Advocacy Manager for Dupont’s pharmaceutical and nutrition business. Her responsibilities include regulatory advocacy for excipients, APIs and food additives. Prior positions include Global Regulatory Affairs Manager for Ashland Inc.’s Pharmaceutical and Nutrition business where she was responsible for regulatory compliance for food additive and excipient products and Quality Manager at FMC BioPolymer (now DuPont Health & Nutrition).
Ms. Zawislak is the Immediate Past Chair of IPEC-Americas, has been a member of IPEC-Americas committees since 2001 and is a member of the Executive Committee. She is also Vice President of the IPEC Federation, a global organization consisting of regional IPECs in the US, Europe, Japan, China and India. She is an IPEC-Americas representative on several USP related committees including the Excipients Project Team, Compendial Process Improvement Team, General Notices Project Team, has served as Chair for several Stakeholder Forums, and is a Delegate to the USP Convention. Priscilla has also participated for over 10 years in the International Food Additives Council and OFCA, a trade association for cellulose derivatives. Priscilla earned her Bachelor degrees in Biological Sciences and Chemistry from the University of Delaware.
Rhonda has been in quality assurance with Biogen for 13 years and has over 25 years experience working in the vaccines, biologics and pharmaceutical industries. She has served in roles successfully supporting product development, marketing approval, launch and post-approval lifeccycle management of multiple products in vaccines and therapeutics for prevention and treatment of Bacterial Pneumonia, Multiple Sclerosis and Hemophilia.