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, University of Lille – APGI |
| 09:30-10:15 | Nitrosamines: Background and Regulatory Landscape Kevin Hugues, Regional Regulatory Director – Colorcon Strategies to reduce nitrite level in pharmaceutical excipients Russel Prestipino, Global Business Manager – Colorcon |
| 10:15-10:45 | JRS Quality management approach Darek Lewin – JRS |
| 10:45-11:15 | Coffee break |
| 11:15-11:45 | Nitrite Analysis in Microcrystalline Cellulose: Challenges and Validation of an IC-CD Method Christian Althanss – JRS |
| 11:45-12:15 | Nitrosamines in practice: APIs and FDFs Sven Wilking – Midas Pharma |
| 12:30-13:45 | Lunch break |
| 13:45-15:15 | Case study: to be confirmed |
| 15:15-15:45 | Coffee break |
| 15:45-16:50 | Methodology for Riks Analysis of Nitrosamine Presence Applied to a Case Study Guillaume Delsart, President of SFSTP Commission on Nitrosamines |
| 16:50-17:00 | Closing remarks Mounira Hamoudi, University of Lille – APGI |