Pharmaceutical Industry and Nitrosamines: from Risk Assessments to Control Strategies
| 08:45-09:15 | Registration & Coffee welcome |
| 09:15-09:30 | Information on partners & Day Mounira Hamoudi – APGI Paul Smith – Colorcon Armelle Six – JRS |
| 09:30-10:00 | Nitrosamines: Background and Regulatory Landscape Kevin Hughes, Regional Regulatory Director – Colorcon and IPEC Federation |
| 10:00-10:30 | Strategies to reduce nitrite level in pharmaceutical excipients Russel Prestipino, Global Business manager – Colorcon |
| 10:30-11:00 | Coffee break |
| 11:00-11:30 | Nitrite Analysis in Microcrystalline Cellulose: Challenges and Validation of an IC-CD Method Christian Althanss, R&D Manager – JRS Group |
| 11:30-12:00 | Statistical Visualization Options for a Data Pool with Nitrite Results for Customer Risk Assessment Darek Lewin, Head of Quality – JRS Group |
| 12:15-13:45 | Lunch break |
| 13:45-14:15 | Nitrosamines in practice: APIs and FDFs Sven Wilking, PhD – Head of Regulatory Affairs, API/Intermediates – Midas Pharma GmbH |
| 14:15-15:15 | Nitrosamines risk management: an overview of the history, current issues and challenges ahead Guillaume Delsart, Regulatory Affairs Expert – Delsart Regulatory Consulting President of SFSTP Commission on Nitrosamines |
| 15:15-15:45 | Coffee break |
| 15:45-16:45 | Risk assessment regarding the presence of nitrosamines in APIs and excipients: SFSTP methodology applied to a case study Guillaume Delsart and Saholy Rakotomanga – SFSTP Commission on Nitrosamines |
| 16:50-17:00 | Closing remarks Mounira Hamoudi, University of Lille – APGI |
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