Info day – 15 May 2025 in Paris - Our speakers

Pharmaceutical Industry and Nitrosamines: from Risk Assessments to Control Strategies

Christian Althanss, R&D Manager – CHP Carbohydrate Pirna GmbH & Co.KG – JRS Group
After completing his Master’s degree at the Technical University of Dresden, Christian has been working as an R&D Manager in the research department at JRS in Pirna since 2023. His primary focus is on the development and implementation of analytical methods for HPLC, GC, and IC. In addition to addressing analytical challenges, he is involved in the research and optimization of synthesis routes. For approximately one and a half years, he has been part of the internal team dedicated to nitrite analysis in excipients, where he is primarily responsible for developing analytical methods for the detection of nitrite in different products.

Guillaume Delsart – Delsart Regulatory Consulting – SFSTP
Founder of DELSART REGULATORY CONSULTING, a regulatory affairs consulting firm (drug products and medical devices), industrial pharmacist, chairman of the SFSTP commission related to nitrosamines, member of the board of Polepharma-SFSTP, who has 10 years experience in regulatory affairs and supplier quality assurance.”

Kevin Hughes, BSc (Hons) – Regional Regulatory Director EMEA – Colorcon
Kevin has been with Colorcon for over 20 years where he is the Regional Regulatory Director for Colorcon EMEA region, supporting customers in both the pharmaceutical and food industries, monitoring regulatory changes and industry initiatives setting regional regulatory strategy.
Kevin is President of IPEC Federation and on the board of IPEC Europe, participates in the IPEC Quality and Regulatory Affairs Committee as chair of the Titanium Dioxide, Nanomaterials and Microplastic task forces.
Before Colorcon Kevin spent 5 years at Boots Healthcare Development, as Team Leader developing solid oral dosage forms.
Kevin graduated with a BSc (Hons) degree in Food Science from Nottingham University in 1994.

Darek Lewin, Head of Quality – JRS Group
After his studies, Darek began at JRS in 2003 as a Project Manager for “Microencapsulation of Probiotic Bacteria.” He developed through several positions: from 2004-2006, he took on more responsibility as Manager for Food and Feed Safety and later as Head of Corporate Quality at JRS Pharma. Since 2007, he has been the Head of Quality for the entire JRS Group, which now maintains over 40 production sites worldwide and provides solutions for various applications and chemical processes with their fiber products.
JRS is a member of IPEC Europe, and Darek actively contributes to the Co-Processed Excipients Task Force and the QRA-Committee. For more than three years, Darek has been focusing on the causes of nitrite in excipients, their analytics and evaluation, as well as fulfilling specific customer requirements.

Russell Prestipino, Global Business Manager-Immediate Release Excipients – Colorcon
Russell has been with Colorcon for 10 years, where he has served as technical manager and business development manager. Currently, he is the Global Business Manager for Colorcon’s immediate release excipients, which include Starch 1500, StarCap, StarTab, Suglets and Nutracore product lines.
Before Colorcon, Russel spent 10 years at Merck in formulation development, process development and clinical manufacturing operations.
Russell graduated with a bachelor’s degree in Chemical Engineering from the University of Virginia is 2004.

Sven Wilking, PhD, Head of Regulatory Affairs API/Intermediates, – Midas Pharma GmbH
Dr. Sven Wilking holds a diploma and a PhD in chemistry from Bielefeld University, Germany.
He has more than 15 years of experience in the pharmaceutical industry, starting in the analytical field and switching to CMC related topics in Regulatory Affairs. He currently works as Head of Regulatory Affairs – API/Intermediates at Midas Pharma GmbH in Ingelheim am Rhein, Germany.
His expertise lies in setup of control strategies and impurities discussions, especially for genotoxic impurities / nitrosamine.

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