USP is hosting user event in Istanbul on February 10th … of course I need to be there to discuss Nitrosamines!
@Turkey, I hope you can join us for the event to learn and discuss the current landscape of Nitrosamines … I want to meet you all!
You can register here: USP user event Istanbul
Where: Crowne Plaza Istanbul - Oryapark, Inkilap Mahallesi Küçüksu Cd, No:58, Istanbul, 34768, Turkey
When: 10/02/2026, 08:30 to 16:30 EEST
USP Event organised together with Azelis.
Agenda (interpretation in Turkish will be available)
08:00 – 08:30 . . . Welcome and Sign in
08:30 – 08:50 . . . Keynotes
Prof. Dr. Ahmet Ayar – TITCK President (invited speaker)
Dr. Zakiya Al-Kurdi – USP Regional Director MEA
08:50 – 10:00 . . . Session 1: Role of USP in the evolving framework of Extractables & Leachable Assessments (Amit Mukherjee, Sr. Manager-Scientific Affairs USP)
• Introduction to Drug Product Packaging
• Current Regulatory Guidance
• Experimental details about the USP Chapters <1663> and <1664>
• Discussion on USP <665> (about to be official in May '26)
• Discussion on the new leachable subchapters (Focus on <1664.2> and <1664.5>)
• Case Studies
• USP Solutions for E&L
10:00 – 10:30 . . . Break
10:30 – 12:00 . . . Session 2: Impurities: A USP Perspective (Dr. Christian Zeine, Sr. Scientific Affairs Manager USP-EMEA)
• Impurities in General
• Guidelines
• USP Approach
• Organic Impurities
• Other impurities
• Elemental Impurities (refer to ICH Q3D)
• Residual Solvents
• Impurities in Excipients
• Pharmaceutical Analytical Impurities
• Q&A
12:00 – 13:15 . . . Lunch
13:15 – 14:30 . . . Session 3: Nitrosamine Impurities (Naiffer Romero, Principal Scientist USP)
• Nitrosamines Impurities Introduction
• Lessons learned & Regulatory Landscape
14:30 – 15:00 . . . Break
15:00 – 16:00 . . . Session 3 contd.
• Nitrosamines Risk Assessment & Testing Challenges
• Q&A
16:00 – 16:30 . . . Closing Remarks