Foley & Lardner LLP looks beyond the law to focus on the constantly evolving demands facing our clients and their industries. With over 1,100 lawyers in 24 offices across the United States, Mexico, Europe and Asia, Foley approaches client service by first understanding our clients’ priorities, objectives and challenges. We work hard to understand our clients’ issues and forge long-term relationships with them to help achieve successful outcomes and solve their legal issues through practical business advice and cutting-edge legal insight. Our clients view us as trusted business advisors because we understand that great legal service is only valuable if it is relevant, practical and beneficial to their businesses.
FDA Practice Group Leader David Rosen is speaking in SAAMnow’s Fall Workshop in the session “Navigating the Whirlwind Surrounding N-Nitrosamine Impurities in APIs and Drug Products” on October 1.
United States
FDA Practice Group Leader David Rosen is speaking in
SAAMnow's Fall Workshop in the session "Navigating the
Whirlwind Surrounding N-Nitrosamine Impurities in APIs and Drug
Products" on October 1.
The workshop will focus on regulatory, scientific, and technical
challenges surrounding the presence of N-nitrosamine impurities in
active pharmaceutical ingredients (APIs) and drug products.
Participants will explore cutting-edge methods, regulatory updates,
and research developments regarding N-nitrosamines.
The workshop will address:
U.S. Food and Drug Administration (FDA) perspective on
N-Nitrosamine Impurities,
International Generic and Biosimilar Medicines Association
(IGBA) perspective on nitrosamine impurities, the worldwide
challenges,
ICH M7 risk assessment and control of N-nitrosamine
impurities,
Over-the counter (OTC) drug products and their challenges with
N-nitrosamine impurities, and
Prescription drug products and their challenges with
N-Nitrosamine impurities.
Foley & Lardner LLP looks beyond the law to focus on the constantly evolving demands facing our clients and their industries. With over 1,100 lawyers in 24 offices across the United States, Mexico, Europe and Asia, Foley approaches client service by first understanding our clients’ priorities, objectives and challenges. We work hard to understand our clients’ issues and forge long-term relationships with them to help achieve successful outcomes and solve their legal issues through practical business advice and cutting-edge legal insight. Our clients view us as trusted business advisors because we understand that great legal service is only valuable if it is relevant, practical and beneficial to their businesses.
