Nitrosamine Impurities - Services for Risk Management
About the Live Webinar
| Title: | “Nitrosamine Impurities – Services for Risk Management” |
| Date | Time | Duration: | September 3, 2024 | 4pm CEST / 10am EST | 30 minutes |
| Speakers | Dr. Helmut Buschmann (Taros Chemicals), Dr. Ranjit Kulkarni (Taros Chemicals) |
This Webinar is a MUST for all API manufacturers and Market Authorization Holder for all AIPs at risk.
These are the Key Learnings for all who are going to attend:
- Nitrosamine contamination remains a key industry concern
- New guidelines refine nitrosamine risk management, emphasiziing stricter controls and compliance
- Effective strategies now involve identifying contamination sources, evaluating processes, and implementing migitation measures
- Updated limits for nitrosamines esure pharmaceuticals meet saftey standards.
- Understanding deviations i nitrosation pathways is crucial for effective risk management.
Speaker 1) Dr. Helmut Buschmann – Chief Scientific Advisor
Helmut holds a PhD from the RWTH Aachen, Germany. After positions hold at Grünenthal GmbH (Aachen), Laboratorius Dr. Esteve S.A. (Barcelona) and SAVIRA Pharmaceuticals GmbH (Vienna) he is now Head of Chemistry, Pharmaceutical Development and Patents at AiCuris GmbH (Wuppertal) and managing director of Research, Development & Consultancy GmbH (Vienna). As a result of his research activities more than 15 NCEs within different therapeutic areas have entered the clinical phase (e.g. Rosonabant, Cizorlitine, Dulopetine, Axamadol). Some of them have reached clinical phase III or are marketed (e.g. Tapentadol: Nucynta® Palexia®,the first co-crystal of 2 APIs Tramadol and Celecoxib Seglentis®).
He has authored and co-authored more than 150 scientific and peer reviewed publications, is named as lead inventor in more than 250 patent families and has edited five books in the field of drug discovery and development. In 2014, he was awarded with the IUPAC-Richter Price for the discovery of the pain killer Tapentadol, which is marketed word-wide as Palexia® (Europe) and Nucynta® (US and Canada).
His research interests are drug impurities and the systematic recording of degradation pathways. He authored one of the first publications describing potential root causes for nitrosamine contamination. Since this time he was invited to several national and international congresses and is consulted as an expert in this field by academic institutes, pharmaceutical companies and regulatory authorities.
Speaker 2) Dr. Ranjit Kulkarni – Team leader Nitrosamine Business Group
Dr. Ranjit Kulkarni is an experienced organic chemist who studied at Humboldt University Berlin. He has over 15 years of experience in chemical development and specializes in the design and synthesis of organic molecules, drug impurities, polymers, and pi-conjugated materials.
His research interests revolve around developing cutting-edge techniques in these areas to advance the field of chemistry. He currently heads the Nitrosamine portfolio at Taros Chemicals and is instrumental in helping pharmaceutical companies by developing solutions to identify and quantify nitrosamine contaminants and provide overall risk assessment.
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