05.21.25 -- A Case For Paying Allogeneic Cell Therapy Product Donors

Explore the complexities of immunogenicity assessment in gene therapy development that focuses on regulatory frameworks in the US and EU, and gain insight into the best practices for global compliance.

Viral Disinfectant Efficacy Studies validate cleaning protocols in pharma facilities, ensuring regulatory compliance, reducing contamination risk, and supporting effective disinfection with expert CRO guidance.

Explore disinfectant residues in cleanrooms—their characteristics, effects, removal challenges, and practical steps to maintain cleanliness and manage residues effectively.

Conducting multi-regional clinical trials (MRCTs) is essential for accelerating oncology drug development and ensuring broader patient access. However, differences across regions can impact findings.

The FDA's Real-World Evidence framework addresses challenges in using Real-World Data for regulatory decisions, emphasizing data reliability, bias management, and successful case studies.

Hear from a 21 CFR Part 11 expert with 20 years of experience helping pharma, diagnostic, and medical device companies achieve compliance.