The Future of

Bio/Pharmaceutical Analysis

Online Summit 2024

Now On-Demand

Speakers

20 June

Speakers

Varun Ahuja

Dr Varun Ahuja

Head-Toxicology, Safety Assessment

Syngene International Ltd

Syngene logo

Dr. Varun Ahuja is a veterinarian and American Board certified as well as European registered toxicologist. He accomplished his Graduation in Veterinary Sciences (BVSc & AH) and Masters (in Veterinary Pharmacology) degrees from G.B.Pant University, Pantnagar, Uttarakhand. He completed PhD in Toxicology from Department of Veterinary Medicine, Freie University, Berlin, Germany. Later on, Varun pursued post-doctoral work from Charité Medical University, Berlin. During his research career, he received fellowships from various prestigious Indian and German organizations.

Varun started his industrial career working as a Study Director at BSL Bioservice Scientific Laboratories in Munich, Germany. Later, he was associated for more than 10 years working in the field of drug discovery and development at Lupin Pharma, Pune. Presently, he is working as Head-Toxicology at Syngene International Ltd., Bangalore.

From a scientific career spanning >20 years, Varun has about 100 publications/presentations. He has presented scientific papers/delivered talks in various meetings in India/Europe/USA. Varun is also involved with organizing various lectures/courses for development of students as well as professionals. Varun is experienced in various domains including drug discovery and development, regulatory toxicology, GLP and risk assessment.

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