Strengthen Regulatory & Quality Excellence to Prevent Costly Setbacks
With European regulatory expectations evolving fast, even small gaps in analytics, CQAs or evidence packages can trigger delays, rework or inspection risk. Our summit brings together MHRA, EDQM, EU Pharmacopoeia and leading biopharma to help you anticipate requirements, design regulator‑ready CMC strategies, and turn analytical data into confident, inspection‑ready decisions. Build clarity early, avoid late‑stage surprises, and progress your mRNA programmes with greater certainty
Sessions Shaping Europe’s mRNA Regulatory Landscape:
4:00 pm 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
4:30 pm Building Measurement Confidence for mRNA Products: Turning Analytics into Regulatory-Ready Decisions
- Defining measurement confidence for mRNA products: moving beyond analytical sensitivity to decision-ready, regulator-trusted evidence
- Translating analytical data into robust quality decisions across the mRNA lifecycle, from early development through clinical and commercial manufacturing
- Designing fit-for-purpose CQAs for mRNA, saRNA, and emerging RNA modalities without over-engineering analytical packages
- The role and limitations of reference materials, pharmacopeial methods, and interlaboratory comparability in building regulatory confidence
- Common CMC evidence pitfalls in mRNA programmes, including false precision, misaligned assay strategies, and late-stage rework — and how to avoid them
- Practical strategies for aligning analytics, process understanding, and regulatory
expectations to enable smoother scientific advice, review, and approval
5:00 pm Embedding European Pharmacopoeia mRNA Standards into CMC & Process Strategies to Ensure Harmonised Quality
- Adapting test methods, acceptance criteria and reference standards to meet European Pharmacopoeia expectations without overburdening development resources
- Assessing how evolving European Pharmacopoeia content interacts with MHRA, EMA and other agency expectations to build a coherent, Europe-ready CMC framework
5:30 pm Aligning mRNA Quality & CMC Strategies with Evolving European Regulatory Expectations
- Interpret how draft mRNA guidelines and ATMP frameworks are shaping regulator expectations for quality, control strategies, and CMC robustness
- Understand how quality considerations are evolving as mRNA applications diversify across indications, modalities, and delivery approaches
- Learn how early scientific advice and engagement with authorities can be used to strengthen CMC packages and de-risk development pathways
Experts Guiding Inspection‑Ready mRNA Development:
Andreea Iftimia-Mander
Head of Analytical and Biological Sciences
Medicines and Healthcare Products Regulatory Agency
Ioannis Rabias
Head of Quality Control Department of Hellenic Pasteur Institute, Member of the Group of Experts for Human Vaccines and Sera of the European Pharmacopoeia
European Directorate for the Quality of Medicines & HealthCare
Join Europe’s end-to-end dedicated community for mRNA Process, CMC and Manufacturing excellence - where regulators, innovators, and technical leaders unite to set the benchmark for quality, cost-effectiveness, and clinical success.
Explore the Full Event Guide
- NEW: 5 World-Leading Regulatory Experts
- NEW: 2 Exclusive AI, Automation & Continuous Purification Workshops
- 12+ Case Studies on Novel mRNA Production Strategies
- 8+ Hours of Dedicated Networking
- 24 Premier Process Development, Quality & CMC Speakers
Attending Companies Include
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Dive into cutting-edge mRNA Process Development & CMC strategies that will become your blueprint to high quality, safe and cost-effective mRNA production.
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