Bruno Spieldenner
Head of Division
Bruno Spieldenner studied physics and chemistry at the University of Strasbourg and holds a Master’s degree in analytical chemistry and spectroscopy from the University of Aix-Marseille.
After graduating, he worked for 7 years as a laboratory engineer for a pharmaceutical company in Switzerland, where he mainly performed analytical procedure development on LC-MS for both small and large molecules.
In 2013, he joined the European Directorate for the Quality of Medicines and Healthcare (EDQM) in Strasbourg, where he worked as a scientific programme manager in the European Pharmacopoeia department.
Since March 2022, he is Head of the Division A for Chemical products and substances, herbals and general methods within that same Department.
DAY 1: NOVEMBER 30th, 2023
SESSION: The EDQM response to nitrosamines
The presentation will start with a short overview of the EDQM and how it fits in the European regulatory system.
The historical evolution from the outbreak of nitrosamines in June 2018 to today and the actions taken on the EU/EC/EMA regulatory level as well as at EDQM will be provided.
Finally, the EDQM response to nitrosamines will be provided by detailing the actions undertaken and still ongoing within the three main tracks that are: the texts of the European Pharmacopoeia, the testing of batchs within the Official Medicines Control Laboratories and the Certification (CEP) procedure.
