Following the success of last year's meeting, join us on 7-8 October at Lhasa Limited (Leeds, UK) for a collaborative event bringing together industry experts and regulators to advance understanding and share insights on nitrites in excipients.
The Agenda of this two half-day meeting features presentations from pharmacopoeias, excipient manufacturers and excipient users. Discover the programme.
This event is open to Lhasa and IPEC Europe members and will also be accessible to online participants.
Attendance at the event is free of charge; accommodation costs are to be covered by the individual attendee.
We’re also pleased to invite you to a group dinner in Leeds city centre, sponsored by IPEC Europe, on the evening of Tuesday, 7 October at The Whitehall restaurant. If you’d like to attend, please register your interest and let us know of any dietary requirements.
We look forward to seeing you there!
Important: this meeting is reserved for IPEC Europe and LHASA members.
Tuesday 7 October 2025
Lunch available; meeting starts at 13:00 BST / 14:00 CEST.
Supporting Nitrites in Excipients through Shared Knowledge with Lhasa and IPEC - Meeting welcome from Grace Kocks, Head of Toxicology at Lhasa Limited
Nitrosamines and Nitrites in Excipients: Ph. Eur. Perspective and Ongoing Reflections - Anne Garnier, Scientific Program Manager at European Pharmacopoeia (EDQM)
Advancing Trace Nitrite Analysis: The Role of Sonication and Insights from IC Method Implementation - Rebekka Spellerberg, Global Application Manager at MEGGLE GmbH & Co. KG
From Excipients to Drug Products: Analytical Development and Control Strategies for Nitrosamine Risks - Jinjian Zheng, Sr. Principal Scientist at MSD
From Method Selection to Risk Evaluation: A Perspective on Nitrite and Nitrosamine Control - Pauline van der Wijst-Janssen, Global Technical Lead at DFE Pharma GmbH
Break at 15:00 BST / 16:00 CEST.
News on IPEC Federation Nitrosamine Questionnaire for Excipients –
Supporting Nitrosamine Risk Assessment for Drug Products - Ulrich Reichert, Head of CDMO and Bioprocess Materials at Merck KGaA
Nitrite Testing in Excipients – Industry Best Practices -Sebastian Hickert, Senior Manager Analytical and Preparative LC at Merck KGaA
From Origins to Outcomes: Trends, Challenges, and Collaboration in Excipients Nitrite Levels - Gemma Packer, Senior Scientist at Lhasa Limited
End of day 1 at 17:15 BST / 18:15 CEST.
Social programme
IPEC Europe sponsors the evening dinner at The Whitehall restaurant in Leeds City centre, starting 18:00 BST / 19:00 CEST.
Wednesday 8 October 2025
Open 9:00 BST, refreshments available. Meeting restarts 9:30 BST / 10:30 CEST.
Nitrite Determination by Ion Chromatography: A Strategic Approach to Nitrosamine Risk Mitigation - Mrunal Jaywant, VP of R&D at USP
Innovative Solutions for Nitrosamine Risk Control - Marianna Pierobon, Global Technical Product Management Pharma Solutions at BASF
Statistical Visualization Options for a Data Pool with Nitrite Results for Customer Risk Assessment - Darek Lewin, Head of Quality, JRS Group
Break 10:45 BST / 11:45 CEST, with coffee and refreshments
Panel session: What is the Root Cause of Nitrite in Excipients?
Lhasa invites collaboration across analytical, regulatory, and manufacturing
perspectives as well as opens the floor for both in-person and online audiences to provide insights, questions and expert remarks. Together, we aim to drive data sharing, collaboration and support on the topic of nitrite in excipient testing.
Supporting panel:
- Sebastien Hickert, Senior Manager Analytical and Preparative LC at Merck KGaA
- Ulrich Reichert, Head of CDMO and Bioprocess Materials at Merck KGaA
- Kevin Moore, Harmonisation team for USP
- Anne Garnier, Scientific Program Manager at European Pharmacopoeia
- Julien Patoor, Director Global Analytical Project Management Late Phase at Novartis
Closing remarks: Lhasa Closing Statement: Thank you to all the speakers, the attendees, and IPEC Europe - Grace Kocks, Head of Toxicology Science at Lhasa Limited
End of day 2 and meeting 12:20 BST / 13:20 CEST.
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