The potential presence of nitrosamines in drug products continues to be a global concern and remains a focus of regulatory agencies worldwide.
IPEC Federation revised its Nitrosamine Questionnaire to ensure alignment with the latest scientific and regulatory developments and to support communication across the pharmaceutical supply chain.
This webinar will provide an overview of the updated version of the Questionnaire, explaining how it assists both excipient manufacturers and marketing authorization holders (MAHs) in gathering and sharing relevant data to support drug product nitrosamine risk assessments, and enabling MAHs to fulfil their regulatory responsibilities.
Join the webinar and gain insights on:
- The role of excipients in nitrosamine risk assessment for drug products
- Background and updates to the IPEC Nitrosamine Questionnaire
- The evaluation of nitrites in excipients and their potential contribution to nitrosamine formation
- Includes dedicated Q&A for the webinar participants
Who should attend?
- Excipient manufacturers, distributors and drug product manufacturers
- Regulatory affairs
- Quality
- Research and development, process development
Date and time
Wednesday 12 November – 15:00-16:00 CET / 14:00-15:00 GMT / 9:00-10:00 ET
Presenters
Jennifer Nette, Perrigo Company, Allegan (Michigan), USA
Ulrich Reichert, Merck Life Science KGaA, Darmstadt, Germany
Registration fees
IPEC Europe Member – free of charge
IPEC-Americas Member – free of charge
IPEC China Member – free of charge
IPEC Japan Member – free of charge
IPEC India Member – free of charge
General Admission – 80 EUR
All fees without VAT.