--- title: "Nitrosamine Risk Assessment: Adapting to the Latest Regulatory Expectations" description: "Manage the risk of nitrosamines in the pharmaceutical industry. Watch our webinar on demand and learn about regulation and risk analysis from experts." url: https://qbdgroup.com/en/webinars/nitrosamine-risk-assessment-adapting-to-the-latest-regulatory-expectations type: "Webinar" language: en published: 2026-03-04 author: "QbD Group" category: "Pharma" publisher: "QbD Group" citation: "QbD Group, \"Nitrosamine Risk Assessment: Adapting to the Latest Regulatory Expectations\", https://qbdgroup.com/en/webinars/nitrosamine-risk-assessment-adapting-to-the-latest-regulatory-expectations" --- # Nitrosamine Risk Assessment: Adapting to the Latest Regulatory Expectations > Manage the risk of nitrosamines in the pharmaceutical industry. Watch our webinar on demand and learn about regulation and risk analysis from experts. Nitrosamine impurities continue to challenge pharmaceutical companies. This webinar will help you understand the regulatory framework, perform effective risk analysis using a clear, science-based, and practical approach. [Learn more](https://qbdgroup.com/en/webinars/nitrosamine-risk-assessment-adapting-to-the-latest-regulatory-expectations#register-here) March 4, 2026 1h Pharma English #### Proactively identify and manage nitrosamine risks Nitrosamine impurities have become a critical and ongoing challenge for the pharmaceutical industry. Regulatory expectations continue to evolve, **acceptable exposure limits****(AELs)**are being reassessed based on evolving toxicological evidence. In this webinar, our experts will explain why nitrosamines should remain a priority for pharmaceutical organizations and how the **regulatory framework** is shaping current and future compliance requirements. You will gain clear insight into the data and inputs needed to perform an **effective nitrosamine risk assessment (NRA)**. We will also explore the **critical factors** that influence nitrosamine formation and how to interpret assessment outcomes to define appropriate actions. The session concludes with **practical case studies and mitigation strategies**, helping you translate regulatory and toxicological concepts into actionable steps for risk minimization. #### What you'll learn - **Understand** what nitrosamine impurities are and why they pose a critical risk to pharmaceutical products. - **Explore** the regulatory landscape, including past developments, current expectations, and upcoming trends. - **Identify** the key data and inputs required for an effective nitrosamine risk assessment. - **Evaluate** critical risk factors and interpret assessment outcomes to support decision-making. - **Discover** practical case studies illustrating strategies to prevent and mitigate nitrosamine formation. **Register now and strengthen your approach to nitrosamine risk management.** ## Register here First name\* Last name\* Role\* Department\* Professional Email\* Company name\* Industry \* Country\* Would you like a one-on-one with our team?\* Content Division (level 2) Content Industry -  Yes, I agree to receive personalized newsletters with market insights, invitations for exclusive events and educational webinars from the QbD Group. \* ![webinar - risk of nitrosamines - QbD Group](https://jrtdedcfhvzaomneervp.supabase.co/storage/v1/object/public/webinar-images/webinars/content/nitrosamine-risk-assessment-adapting-to-the-latest-regulatory-expectations/webinar_-_riesgo_de_las_nitrosaminas_-_QbD_Group.jpg) ## Who should attend? - **Quality Assurance**(QA) and **Quality Control** (QC) professionals are responsible for ensuring product compliance - **Regulatory Affairs**(RA) professionals involved in regulatory strategy, submissions, and interactions with regulatory authorities - **CMC, manufacturing, and technical operations** teams supporting nitrosamine risk assessments and mitigation strategies - **Technology Transfer** professionals involved in process and product knowledge transfer across development and manufacturing stages - **Formulation and Pharmaceutical Development (R&D) teams** involved in product and process design with potential impact on nitrosamine risk [Learn from our experts](https://qbdgroup.com/en/webinars/nitrosamine-risk-assessment-adapting-to-the-latest-regulatory-expectations#register-here) ## Speakers Our speakers bring **hands-on experience** from toxicology, regulatory compliance, and pharmaceutical development. They will **translate complex scientific and regulatory requirements into practical guidance** that you can apply in your daily work. #### Pablo Palomar Toxicology Consultant Pabloholds a degree in Chemistry and a Master’s degree in Organic Chemistry from the Autonomous University of Madrid (UAM). He currently works as a Toxicology Consultant at QbD Group, with a strong focus on nitrosamine-related regulatory requirements. With over five years of experience in organic synthesis and drug development, he has worked in multiple research laboratories and developed hands-on expertise in a wide range of analytical techniques. ![Natalia Herrera](https://jrtdedcfhvzaomneervp.supabase.co/storage/v1/object/public/webinar-images/webinars/content/nitrosamine-risk-assessment-adapting-to-the-latest-regulatory-expectations/Natalia_Herrera.png) #### Natalia Herrera Global Toxicology Liaison She holds a PhD in Pharmacy from the University of Medical Sciences of Costa Rica and a Master’s degree in Drug Research, Development and Innovation from the University of Navarra. With a strong background in business development, she previously worked at a preclinical CRO, where she played a key role in driving growth and establishing strategic partnerships. Her professional experience also includes roles as a Medical Sales Representative at several companies, including Abbott. In addition, she has gained valuable experience in quality assurance through her work at Pfizer and other pharmaceutical manufacturing sites, ensuring compliance with industry standards. [Reserve your spot](https://qbdgroup.com/en/webinars/nitrosamine-risk-assessment-adapting-to-the-latest-regulatory-expectations#register-here) ![Toxicology - Nitrosamine](https://jrtdedcfhvzaomneervp.supabase.co/storage/v1/object/public/webinar-images/webinars/content/nitrosamine-risk-assessment-adapting-to-the-latest-regulatory-expectations/Toxicology_20-_20Nitrosamine.png) ## Worried about Nitrosamine compliance? ## Resources you might find interesting ![preview_image](https://jrtdedcfhvzaomneervp.supabase.co/storage/v1/object/public/webinar-images/webinars/content/nitrosamine-risk-assessment-adapting-to-the-latest-regulatory-expectations/Diseno-sin-titulo-1-4-2.jpg) Blog #### Nitrosamine Impurities in Medicinal Products: Risks and Regulatory Insights The emergence of nitrosamine impurities In June 2018, regulatory... [Read More](https://qbdgroup.com/en/blog/nitrosamine-impurities-in-medicinal-products-risks-and-regulatory-insights) ![preview_image](https://jrtdedcfhvzaomneervp.supabase.co/storage/v1/object/public/webinar-images/webinars/content/nitrosamine-risk-assessment-adapting-to-the-latest-regulatory-expectations/New_Update_of_Appendix_1_of_the_Nitrosamines_Guideline_2_-_RA_Update.jpg) Blog #### New Update of Appendix 1 of the Nitrosamines Guideline - EMA/42261/2025/Rev. 11 What's new? This update introduces the Acceptable Intake (AI) values for new... ![preview_image](https://jrtdedcfhvzaomneervp.supabase.co/storage/v1/object/public/webinar-images/webinars/content/nitrosamine-risk-assessment-adapting-to-the-latest-regulatory-expectations/How_to_Prepare_a_Submission-Ready_Environmental_Risk_Assessment__ERA_.jpg) Blog #### How to Prepare a Submission-Ready Environmental Risk Assessment (ERA) Environmental Risk Assessment (ERA) is a mandatory part of the... [Read More](https://qbdgroup.com/en/blog/environmental-risk-assessment-ema-guideline) ![preview_image](https://jrtdedcfhvzaomneervp.supabase.co/storage/v1/object/public/webinar-images/webinars/content/nitrosamine-risk-assessment-adapting-to-the-latest-regulatory-expectations/Environmental-Risk-Assessments-ERA-in-Pharma-Balancing-Health-Environment--2.png) Blog #### Environmental Risk Assessments (ERA) in Pharma: Balancing Health & Environment As we strive to improve our health with new medicines, it’s crucial... [Read More](https://qbdgroup.com/en/blog/environmental-risk-assessments-era-in-pharma-balancing-health-amp-environment) ![preview_image](https://jrtdedcfhvzaomneervp.supabase.co/storage/v1/object/public/webinar-images/webinars/content/nitrosamine-risk-assessment-adapting-to-the-latest-regulatory-expectations/Toxicological-Assessment-of-Extractables-and-Leachables-2.jpg) Blog #### Toxicological Assessment of Extractables and Leachables (E&L) Ensuring the safety and efficacy of pharmaceutical products involves more... [Read More](https://qbdgroup.com/en/blog/toxicological-assessment-of-extractables-and-leachables) Blog #### Environmental Risk Assessment (ERA) in Drug Products: Understanding the EMA Guideline Balancing human health, regulatory compliance, and environmental... [Read More](https://qbdgroup.com/en/blog/environmental-risk-assessment-update) ![preview_image](https://jrtdedcfhvzaomneervp.supabase.co/storage/v1/object/public/webinar-images/webinars/content/nitrosamine-risk-assessment-adapting-to-the-latest-regulatory-expectations/RA_update_-_ICH_Draft_Q3E_Guideline_on_Extractables___Leachables_Now_Open_for_Consultation.jpg) Blog #### ICH Draft Q3E Guideline on Extractables & Leachables Now Open for Consultation This milestone represents a decisive step toward harmonizing international... ![preview_image](https://jrtdedcfhvzaomneervp.supabase.co/storage/v1/object/public/webinar-images/webinars/content/nitrosamine-risk-assessment-adapting-to-the-latest-regulatory-expectations/RA-Update-Elemental-Impurities-Veterinary-medicinal-prodcuts.png) Blog #### EMA launched a new draft guideline on risk management requirements for elemental impurities in veterinary medicinal products Last October, the EMA launched a new draft for public consultation on the risk... ![preview_image](https://jrtdedcfhvzaomneervp.supabase.co/storage/v1/object/public/webinar-images/webinars/content/nitrosamine-risk-assessment-adapting-to-the-latest-regulatory-expectations/The_FDA_releases_revision_of_guidance_regarding_Control_of_Nitrosamine_Impurities_in_Human_Drugs.png) Blog #### The FDA releases revision of guidance regarding Control of Nitrosamine Impurities in Human Drugs What’s new? Here are the key updates on the FDA’s revision of the guidance on... ![preview_image](https://jrtdedcfhvzaomneervp.supabase.co/storage/v1/object/public/webinar-images/webinars/content/nitrosamine-risk-assessment-adapting-to-the-latest-regulatory-expectations/New_Update_of_Appendix_1_of_the_Nitrosamines_Guideline.jpg) Blog #### New Update of Appendix 1 of the Nitrosamines Guideline What’s new? In this update, the Acceptable Intake (AI) values for nitrosamines... --- Source: https://qbdgroup.com/en/webinars/nitrosamine-risk-assessment-adapting-to-the-latest-regulatory-expectations — © QbD Group. Quote freely with attribution and a link back.