Dublin, Nov. 13, 2026 (GLOBE NEWSWIRE) -- "The Regulatory Requirements on Nitrosamines in the Pharmaceutical Industry (Apr 19th - Apr 20th, 2027)" has been added to ResearchAndMarkets.com's offering.
Nitrosamine regulations represent one of the most significant changes affecting the pharmaceutical industry in recent years. Current regulatory requirements are estimated to affect 30% of existing and new products, including generic medicines, creating substantial compliance, assessment and resource challenges for pharmaceutical companies worldwide.
This six-hour webinar provides a structured overview of the evolving regulatory landscape for nitrosamines, with a focus on major requirements, practical compliance strategies and common areas of regulatory concern. As expectations continue to change and approaches vary between global markets, the course will help participants develop a clearer understanding of the factors that must be considered when managing nitrosamine risks across pharmaceutical product portfolios.
The programme is suitable for professionals who are new to nitrosamine regulations, organisations establishing or expanding specialist teams, and experienced industry personnel seeking practical guidance on complex compliance activities. Participants will gain a consolidated view of the subject while exploring how regulatory expectations can influence current products, new product development and generic medicines.
A key focus of the webinar is the preparation and management of nitrosamine risk assessments. These assessments remain a common challenge for pharmaceutical businesses due to changing requirements, differences between jurisdictions and the need to evaluate product-specific risks. The course will provide detailed instruction on recurring pain points and support participants in approaching risk assessment activities with greater consistency and regulatory awareness.
Professionals working in Small and Medium-sized Enterprises (SMEs) may find the webinar particularly valuable, as it addresses the practical demands associated with interpreting requirements and supporting compliance programmes with proportionate resources. The content is also relevant to larger organisations seeking to strengthen internal knowledge, align teams and improve oversight of nitrosamine-related activities.
By presenting the major requirements within a single programme, the webinar will enable attendees to better understand the broader regulatory picture and identify areas that may require additional attention. The course is designed to support informed decision-making, improve cross-functional understanding and help organisations respond more effectively to ongoing regulatory developments.
Relevant participants may include professionals involved in regulatory affairs, pharmaceutical development, quality assurance, quality control, manufacturing, analytical activities, product lifecycle management and compliance. It may also benefit technical specialists and team leaders responsible for developing or implementing organisational strategies related to nitrosamine requirements.
Attendees will have the opportunity to strengthen their knowledge of global nitrosamine regulations, examine practical strategies for meeting regulatory expectations and build confidence in addressing risk assessment challenges. The webinar's combination of broad regulatory context and detailed practical instruction makes it appropriate for participants with varying levels of experience.
CPD Hours: 6
Who Should Attend?
This course will benefit nitrosamine decision makers and those who can benefit from a broader understanding of the full picture of nitrosamines in regulatory affairs, sales, quality, and analytical departments.
Key Topics Covered:
- Day 1
- History and background
- Classes of nitrosamines
- Regulatory update
- Team building
- Risk assessments
- At risk structures
- Limit determination
- Day 2
- Nitrosation Assay Procedure (NAP) test
- Analytical instruments and methods
- Control strategy
- Remediation
- Post approval changes
- Where are we going? Future state and unanswered questions
Speaker
Jason Brown
Jason Brown brings a wealth of knowledge and practical experience to his role as Senior Analytical Sciences Manager at Adare Pharma Solutions, where he serves as the global nitrosamine subject matter expert. He has led Adare's innovative approaches to understanding nitrosamine formation, measurement, and mitigation to ensure regulatory compliance internally and for our customers. Jason has led numerous dialogues on the subject of nitrosamines through panel discussions, webinars, posters, articles, and regular contributions to the USP Nitrosamine Forum. Jason has a BS in Chemistry from George Fox University.
For more information about this training visit https://www.researchandmarkets.com/r/vfvn1q
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