We were delighted to return to Brasilia this year to host the Pharmaceutical Industry and Regulators Symposium!
Supported by Sindusfarma and the Federal Council of Pharmacy, this two-day event featured insightful presentations delivered by speakers from both industry and regulators.
The Symposium brought together like-minded industry experts and regulators, offering attendees a unique opportunity to share knowledge gaining a greater understanding of the new science and technologies used to address regulatory requirements.
Some key topics covered during the event included mutagenic impurities and control options under ICH M7, challenges in N-nitrosamines assessments, and read-across. We addressed how in silico tools can support the new requirement for degradation studies, with regulatory perspectives, and the application of these tools for extractables and leachables.
There was opportunity for networking following each day of the symposium.