We are happy to announce our second webinar of the series we have prepared!
In particular, our Carla Landolfi, European Registered Toxicologist (ERT) and the Founder & CEO of ToxHub Srl, will talk about nitrosamines in native pharmaceutical ingredients, with a particular focus on how to determine their acceptable intakes.
Nitrosamines are potentially carcinogenic compounds that can form during the manufacturing process of certain pharmaceuticals, particularly those containing secondary or tertiary amines. Due to their highly hazardous characteristics regulatory authorities, such as the FDA and EMA, provide guidelines and limits for nitrosamine impurities in pharmaceutical products, emphasizing the need for manufacturers to implement robust risk assessment and control measures. In fact, by thoroughly evaluating nitrosamine impurities and establishing acceptable intake levels, pharmaceutical manufacturers can mitigate potential risks to patient health and ensure the safety and efficacy of their products.
To determine their acceptable intake levels, rigorous assessments are conducted, considering factors such as mutagenicity and carcinogenicity. However, some uncertainties are still present, in particular regarding how to assess the toxicological risk, how to handle impurities in the absence of data, and therefore which in vitro or in vivo tests to carry out in order to define safe limits. To address these doubts, in October 2023, the European Medicines Agency (EMA) updated for the nineteenth time the guideline on nitrosamine impurities: “Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products”. In particular, the Agency modified, among others, question and answer (Q&A) No. 10 to include the Carcinogenic Potential Categorization Approach (CPCA), providing guidance on the adapted Ames test (EAT) protocol and establishing acceptable intakes (AI) for N-nitrosamines.
In the webinar, we will delve deeper into nitrosamines, considering different ways in which acceptable intakes are obtainable. Places are limited, and all attendees will be issued a certificate of participation.
Speaker
Carla Landolfi
European Registered Toxicologist (ERT); Toxicology Risk Assessor; Founder & CEO of ToxHub Srl.
As a European Registered Toxicologist, Carla Landolfi has spent 25 years within the pharmaceutical industry as Head of Toxicology at Angelini, among others. Having expertise in pharmaceuticals and medical devices safety assessments (MDR/FDA/GLP/ISO), she is the founder of ToxHub, specialized in toxicological risk assessment and regulatory strategy consulting. She is a frequent author of publications and founding editor of Archives of Clinical Toxicology.
Date, Time and Language
May 17th, 2024, from 12.00 to 13.00 PM, CET (Central European Time).
This webinar will be held in English.
The Webinar will address the following topics:
- Nitrosamines,
- Latest regulatory indications,
- Overview of Acceptable Intakes,
- How to derive Acceptable Intakes,
- Q&A
Are you interested in joining our webinar? To register, simply fill out the registration form below with your information! Registration is free and open till May 15th!