Neotron, Innovatune, and CMC Pharmatech invite you to an exclusive webinar on 25 March 2026 at 11:00 AM CET.
We are pleased to invite you to an exclusive webinar by Neotron, in partnership with Innovatune and CMC Pharmatech, on 25 March 2026 at 11:00 AM CET.
Nitrosamine management is currently one of the most critical scientific and regulatory challenges for the pharmaceutical industry. Effective control requires a risk-based approach across the entire product lifecycle, integrating regulatory, analytical, and toxicological expertise.
This webinar session aims to provide a multidisciplinary perspective supported by real case studies and practical strategies.
Key Points
CMC Pharmatech
- Introduction to nitrosamines: what they are, why they are hazardous, and EMA guideline requirements
- Risk assessment and awareness of extremely low limits (e.g., 100 ng vs substance-specific AIs)
- Holistic project evaluation rather than fragmented phase-based assessment
- Real case study
- Formation in the API
- Formation in the finished product
- Formation during storage
- Analytical strategies and mitigation measures to reduce risk
Neotron
- Regulatory framework overview
- Evolution of analytical strategies for nitrosamine detection
- Support services: risk assessment, method development and validation, stability studies, API–excipient interaction assessment
- General approach: client request → reference standard availability → method development → method validation
- Real case study
Innovatune
- Toxicological regulatory framework for nitrosamines
- Scientific basis of carcinogenicity and risk-based decision making
- Derivation of acceptable intake (AI) limits
- Structure-based approaches, including the Carcinogenic Potency Categorization Approach (CPCA)
- Use of read-across, in silico tools, and experimental data to support regulatory justifications
- Toxicological evaluation of the real case study
Register now to secure your spot!
We are excited to welcome you to this engaging webinar.