Benchmarking Regulatory Strategies in an Uncertain Landscape: How Biotech & Pharma are Approaching mRNA Quality, Risk & Engagement

• 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

Speakers:

Katharina Mueller

Senior Specialist - Quality Assurance Regulatory

BioNTech