The Future of

Bio/Pharmaceutical Analysis

Online Summit 2024

Now On-Demand

Speakers

20 June

Speakers

Malcolm Ross

Dr Malcolm Ross

Analytical Specialist - External and Member of Nitrosamine Task Force

Novartis

Novartis logo

Dr. Ross has over 35 years experience in the Generics Industry, the last 15 being at corporate level. He has been intimately involved in strategic planning, pipeline management and related activities. His early industrial experience with Teva and Taro were directed primarily to the US markets but later, as President of IPR, a company jointly owned by PAR and Merck Generics, followed by R&D director for Polpharma, his role expanded to include development for the European markets.

Technically Malcolm specialized in development, both of formulations and analytical methodologies and holds a number of patents for novel formulations. In 2006 Malcolm moved to Basel and has worked for Novartis in several roles as well as consulting for a wide range of companies on strategic planning and technical matters. He has conducted many training courses throughout Europe and Asia.

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