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.
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:
Head-Toxicology, Safety Assessment
Syngene International Ltd
Senior Applications Chemist
Ellutia
Senior Manager, Nitrosamine Testing and Analytical Technologies
TEVA Pharmaceuticals
Director of R&D
Cambrex
Analytical Specialist - External and Member of Nitrosamine Task Force
Novartis
Regulatory Compliance SME, Founding Expert Member and Nitrosamine Exchange Ambassador
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