Katharina Mueller
Associate Director, Regulatory Compliance & Quality Analyst BioNTech
Seminars
Wednesday 20th May 2026
Benchmarking Regulatory Strategies in an Uncertain Landscape: How Biotech & Pharma are Approaching mRNA Quality, Risk & Engagement
4:00 pm
- Comparing how biopharma interprets evolving guidance across potency, impurities and raw materials to apply risk-based, platform approaches to maintain compliance and product quality while progressing mRNA programmes
- Examining processes, cross-functional review structures and escalation pathways used by industry to adjudicate regulatory grey zones and establish consistent, inspection-ready quality decision
