Diane McCarthy

As mRNA pipelines diversify beyond infectious disease, regulatory clarity is more critical than ever. This interactive session arms you with a clear view of how regulators are thinking, where common analytical pitfalls trigger failures, and how to build assays and release strategies that stand up to scrutiny. Expect a practical, forward-looking discussion that translates evolving regulatory requirements and standards into actionable steps to safeguard submissions, avoid costly delays, and future-proof your AD & QC programs. 

Join to:

• Navigate how shifting regulatory requirements impact assay development, release testing, and extended characterization to strengthen analytical robustness and keep pace with innovation
• Compare regulatory vs. industry priorities in building analytical and CMC packages to understand where expectations align and where gaps commonly arise
• Overcome analytical shortcomings to drive regulatory submission success and future-proof your AD & QC strategies and safeguard program success