Info day – 15 May 2025 in Paris

Pharmaceutical Industry and Nitrosamines: from Risk Assessments to Control Strategies

organized with

• The Introduction will open the day by addressing the context and regulatory environment
• We will discuss the approach to excipient-related aspects, particularly in relation to starch and MCC
• Quality management approach
• Challenges in the analytical dosing of nitrosamines in excipients
• A presentation on risk analysis and strategies they use to avoid the need to dose nitrosamines in their products (with concrete examples on active ingredients and finished products)
• Practical case studies with feedback on their respective processes