The Future of

Bio/Pharmaceutical Analysis

Online Summit 2024

Now On-Demand

Speakers

20 June

Speakers

Ingrid Hegbom Ekman

Ingrid Hegbom Ekman

Director of R&D

Cambrex

Cambrex logo

Ingrid Hegbom Ekman joined Cambrex’s Karlskoga facility in 1994 and was responsible for the Technology Platform and was a responsible chemist for Cambrex Fine Chemicals. In 2002, she became Manager, R&D Process Development and Project Manager. Since 2006, she has been the Director of Research and Development for the facility. She has a Doctor of Technology from the Norwegian Institute of Technology, Department of Organic Chemistry (NTNU) and graduated in 1994.

Ellutia logo
Panel

10.30 – 12.00 am CET

Nitrosamine contamination

Is it still an issue today?

Almost six years after N-nitrosodimethylamine (NDMA) contamination was first identified, the toxic short alkyl chain N-nitrosamine issue appears on the way to resolution. In contrast, N-Nitrosamine drug substance-related impurities (NDSRIs) are still a burgeoning issue with many new NDSRIs being reported on a weekly basis. This session will:

  • Review the latest guidelines on nitrosamine risk evaluation and risk assessment
  • Explore analytical techniques for determination of nitrosamine impurities
  • Discuss the path to international regulatory harmonisation.
Varun Ahuja with Syngene logo

Varun Ahuja

Head-Toxicology, Safety Assessment
Syngene International Ltd

Jonathan Angove with Ellutia logo

Jonathan Angove

Senior Applications Chemist
Ellutia

Ivana Gusić with Teva logo

Ivana Gusić

Senior Manager, Nitrosamine Testing and Analytical Technologies
TEVA Pharmaceuticals

Ingrid Hegbom Ekman with Cambrex logo

Ingrid Hegbom Ekman

Director of R&D
Cambrex

Malcolm Ross with Novartis logo

Malcolm Ross

Analytical Specialist - External and Member of Nitrosamine Task Force
Novartis

Archana Bahuguna

Moderator: Archana Bahuguna

Regulatory Compliance SME, Founding Expert Member and Nitrosamine Exchange Ambassador