Join us for an in-depth session abput “Biological Impurities: Scientific and Regulatory Aspects”, where our Regulatory Affairs expert Mario López de la Cruz will guide you through the scientific complexities and evolving regulatory landscape surrounding biological products.
This webinar offers a practical overview of how impurities in biological medicines are identified, evaluated, and controlled under both European and U.S. regulatory frameworks. Whether you’re in R&D, regulatory affairs, or quality assurance, this session is designed to help you confidently navigate the complex challenges of biologics.
The webinar will cover:
- Definitions and particularities of biological products according to EU and US regulations
- Key regulatory guidelines, including those from ICH, EMA, and FDA
- Scientific complexity and control strategies for impurities in biological products
Registrations are now open! Reserve your spot here: https://bit.ly/4dbT25q
Need expert support with your biologic’s development or regulatory strategy?
📩 Contact us at: [email protected]