An industry perspective of the current regulatory landscape for nitrosamines

The regulatory landscape for N-nitrosamines (nitrosamines) in pharmaceuticals is evolving. Following the initial product recalls of 2018 and issuance of Article 31 and Article 5(3) relating to nitrosamines concern, our invited speaker, Lance Smallshaw, and industry colleagues formed the EFPIA Nitrosamines Working Group. Over the last 5 years there has been an abundance of guidance, Q&As and pharmacopoeia general chapters from worldwide health authorities: ANVISA, FDA, EMA, Health Canada, Swissmedic, MHRA, PDMA, relating to both the control of simple N-nitrosamines: NDMA, NDEA, and the more recent discovery of the complex API derived nitrosamines (NDSRIs).

In this webinar, Lance Smallshaw, Head of Compendial Affairs at UCB Pharma S.A. (Belgium), will provide an overview of the regulatory landscape today including recent significant updates related to nitrosamines in human medicines. This webinar will also offer a perspective on the differences that exist between the health authorities, and explain how there is a continued need from the industry, to do more in order to harmonize these regional differences.

Key learning objectives

• Understand the nitrosamine situation over the past five years and the impact on the pharmaceutical industry

• Discover key aspects of the latest regulations related to determining risk in new nitrosamines and understand the role of industry working groups

• Explore the continued need for harmonization between regional health authorities to tackle the global challenge of control of nitrosamines in pharmaceuticals

Who should attend?

• Those working in pharmaceutical analytical development, pharmaceutical QA/QC, and regulatory in innovative and generic pharma, contract testing, and research and manufacturing organisations (CTO, CRO, CDMO).

Certificate of attendance

All webinar participants can request a certificate of attendance, including a learning outcomes summary, for continuing education purposes.

Presenter: Lance Smallshaw (Head of Compendial Affairs at UCB Pharma S.A.)

Lance Smallshaw has 42 years’ experience in the pharma and biopharma industry. He spent 30 years at Eli Lilly and Company and for the past 12 years, he has worked at UCB Pharma S.A. (Belgium), where he is currently the Head of Compendial Affairs / Global Analytical Expert within the Regulatory Intelligence Network of UCB Global Sites Quality Operations. He has led QC Analytical Services, was Head Senior Scientist (Analytical Development), headed the Stability Operations Team, and been QA Representative for human and veterinary products, leading international technology transfer. At UCB, Smallshaw has led the development and strategy and worldwide implementation of ICH Q3D and ICH M7. Externally, as well as academic associate professor lectureships, his grounding in GMP and cGMP law has led to his co-chairing the executive foundation board of the ECA. In 2018, Smallshaw joined the EFPIA N-Nitrosamines Working Group.

Presenter: Ellen Simms (Assistant Editor, SelectScience)

Ellen studied biological sciences at the University of the West of England, UK, before completing a master's in epidemiology from the University of Bristol. As a member of the Editorial team, she now plays an integral role in shaping the content on SelectScience.