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Nitrosamines: Traceability / Sensitivity - What is Good Enough?
Session Chair(s)
Sylvie Meillerais, MSc
Director Global CMC Policy
MSD Belgium, Belgium
This DIAlogue session will gather Regulators from the EU network and other countries, and industry experts to reflect on progress with the nitrosamines impurities risk evaluation, and how these have advanced the knowledge and understanding of the potential risk factors. It will also address lessons learned, the benefits of regulatory Agencies’ collaboration and the importance of global standards and on this topic including to maintain patients’ safety and confidence in medicines globally.
Speaker(s)
Panelist
Robert Bream, PhD, MA, MS
European Medicines Agency, Netherlands
Pharmaceutical Quality Senior Specialist
Panelist
Jalene W.W. Poh, RPh
Health Sciences Authority , Singapore
Director, Vigilance & Compliance Branch
Panelist
Stephen Horne, PhD
Health Canada, Canada
Senior Evaluator,Bureau of Pharmaceutical Sciences
Panelist
Valerie Niddam-Hildesheim, PhD
Teva, Israel
Global Nitrosamines project lead
Panelist
Matt Popkin, PhD
GSK, United Kingdom
Senior Director, CMC Excellence, Global Regulatory Affairs
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