We were delighted to host the Lhasa Brazil Symposium: Aligning Pharma & Regulatory Standards Globally, which took place in São Paulo, Brazil.
The one-day event on Monday, 14th July, brought together key representatives from the pharmaceutical industry and regulatory bodies, encouraging collaboration and aligning Brazil with global best practices.
Throughout the day, attendees gained essential knowledge and practical tools to:
- Navigate regulatory changes – Understand how the new RDC 964/2025 guidelines on degradation studies will impact your processes and how to use in silico tools to confidently build the scientific rational needed for justifications on the degradation space.
- Stay ahead of global trends – Gain insights into the EMA’s latest reflection paper and its implications for pharmaceutical development.
- Strengthen risk assessment strategies – Learn how in silico tools can support acceptable intake setting, extractables and leachables analysis and more.
- Address nitrosamine challenges – Discover strategies for managing nitrosamine impurities, including proposing read-across analogues that are both achievable by quality measures and protective of human health. Hear from global regulators and leading industry voices in a roundtable discussion on the most effective ways to achieve compliance in this complex and fast-moving area of impurity management. See how our in silico solutions and data-sharing initiatives can streamline your nitrosamine workflows and reduce testing burden, while stimulating advances in research.