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Ensuring Quality throughout the Supply Chain – Update on nitrosamine impurities case
Session Chair(s)
Fergus Sweeney, PhD
Head of Clinical Studies and Manufacturing Task Force
European Medicines Agency, Netherlands
Ensuring Quality throughout the Supply Chain – Update on nitrosamine impurities case
Learning Objective : • Discuss causes for contamination and identify actions taken by regulatory authorities and manufacturers to mitigate risk • Identify the challenges to dealing with the case • Discuss lessons learnt by industry and regulatory authorities
Speaker(s)
N-nitrosamine Impurities Case update
Andrei Spinei, MPharm, MSc
European Medicines Agency, Netherlands
Scientific Administrator
Dealing with the nitrosamines issue in Canada
Gary Condran
Health Canada, Canada
Manager, Quality Risk Management and Operations Division, Bureau of Pharmaceutic
Guidance to avoid nitrosamines in human medicines - NCA/CMDh perspective
Kora H Doorduyn-van der Stoep, MSc, RPh
MEB, Netherlands
EU Representative
N-Nitrosamines - Industry Perspective
Ron Ogilvie
Pfizer, United Kingdom
CMC Advisor
Panelist:
Priscilla Schoondermark
Medicines Evaluation Board, Netherlands
NL-CMDh alternate
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