10.09.24 -- Global Regulatory Challenges Of Rare Diseases

The EMA has taken a collaborative approach with its updated ATMP guideline, aiming to streamline development and clarify regulatory expectations for cell and gene therapies across Europe's landscape.

Compliance with biosafety levels (BSLs) is crucial in ensuring that your laboratories meet stringent standards to protect staff and prevent the escape of biological agents.

Explore the most recent rewrite of the EU Annex 1 document as well as the contamination control strategy outlined within.

In addition to codifying some best practices, R3 recommends that sponsors adopt an approach to identifying and managing areas of risk to mitigate potential issues and enhance overall success.

With the FDA's final compliance deadline for the Drug Supply Chain Security Act (DSCSA) nearing, organizations must assess their readiness to meet these regulatory requirements.

By proactively addressing recurring deficiencies in Design Controls and risk management, manufacturers can ensure FDA compliance and prioritize patient safety and device effectiveness.