WEBINAR
N-Nitrosamines continue to be a global concern.
Regulators requested drug product manufacturers to identify products at risk of N-nitrosamine formation or contamination. The implications could impact the pharmaceutical industry supply chain.
The pharmaceutical community’s understanding of N-nitrosamine formation in drug products, including the potential impact from excipients, continues to evolve.
This webinar provides an overview of the role of excipients in drug product risk assessments and the accompanying IPEC Federation position paper.
In addition, the webinar includes best practices and examples for communication between excipient suppliers and users. Open communication between drug product manufacturers and excipient suppliers is required to ensure the appropriate information is obtained to inform risk assessments on drug products.
Who should attend?
> Excipient manufacturers, users, distributors
> Regulatory affairs
> Compendial affairs
> Quality affairs
SPEAKERS
Elizabeth Tocce, IFF, United States
Elizabeth Tocce is a lead applications scientist for IFF Pharma Solutions and is an active member of the IPEC-Americas Nitrosamine Cross Functional Team and Quality-by-Design Committee. Elizabeth Tocce joined the IFF Pharma Solutions team in 2018 as a Pharma Application Development Scientist. In this role, she provides technical support to pharmaceutical customers and project leadership on growth and innovation projects using IFF’s pharmaceutical excipients. Prior to her role with IFF, Elizabeth was a research and development scientist for The Dow Chemical Company’s Pharma & Food Solutions excipient business where she led R&D projects in areas of specialty oral solid dosages and quality improvement. Elizabeth received her PhD in Chemical and Biological Engineering from the University of Wisconsin – Madison in 2011 and a bachelor’s degree in Chemical Engineering from Purdue University in 2005. She currently lives in Ann Arbor, MI, with her husband and two kids.
Ulrich Reichert, Merck, Germany
Ulrich Reichert heads the "Regulatory Management – CDMO and Bioprocess Materials” organization of the Life Science business of Merck KGaA, Darmstadt, Germany. He is pharmacist by training, holds a PhD and a Master of Drug Regulatory Affairs and has more than 20 years of experience in quality and regulatory requirements for raw and starting materials in pharmaceutical industry. Ulrich is member of the nitrosamine task force of IPEC Europe and led the same of the Life Science business sector of Merck KGaA, Darmstadt, Germany.
SESSIONS
Session 1 – for an audience based in Europe/Americas – Tuesday 16 July – 16:00-17:00 CEST / 10:00-11:00 EDT
Session 2 – for an audience based in Asia/Europe – Wednesday 17 July – 9:00-10:00 CEST / 12:30-13:30 IST / 15:00-16:00 CST / 16:00-17:00 JST
PRACTICAL INFORMATION
The webinar will be run twice and will follow the same structure.
The link to connect to the session chosen will be shared shortly before the event starts.
