About ATMP CMC: Regulatory Strategy, Analytics & Commercialization | Advanced Therapies Workshops | #EGeneCell 2026

Join leading CMC strategists, regulatory directors, assessors, analytical development leads, and global submission experts for an intensive workshop dedicated to the regulatory and scientific foundation of ATMP, gene therapy, biologics, and mRNA development. 

This workshop continues the Advanced Therapies Workshop Series because regulatory understanding and analytical rigour are the foundation everything else is built on. Before your team can manufacture compliantly or build a quality system that holds up under inspection, they need to understand what regulators actually require — and have the characterisation, potency, and comparability data to prove it.

Covering the full regulatory and CMC lifecycle from early scientific advice through CQA definition, potency assay design, comparability, and post-approval change management, this is the most strategically important workshop in the series for anyone whose decisions affect what goes into a regulatory submission.

 Why Attend?

• CMC-Regulatory Alignment — understand how to synchronise CMC development timelines with regulatory submission requirements to avoid last-minute surprises
• Assessors' Perspective on CMC Packages — hear directly what EMA, FDA, and MHRA reviewers look for, and what consistently disappoints them
• CQA Definition & Control Strategy — apply QbD principles to identify and prioritise critical quality attributes and build control strategies that satisfy ICH Q8/Q9/Q10
• Potency Assays Under Regulatory Scrutiny — design and qualify potency assays that demonstrate clinical relevance, biological consistency, and regulatory acceptability
• Comparability Strategy & Post-Change Management — design comparability studies that satisfy EMA and FDA expectations following process changes, scale-up, and CDMO transitions
• Top CMC Deficiencies in ATMP Submissions — review the most common, most costly mistakes in regulatory dossiers and analytical packages, and how to avoid them
• Post-Approval Change & Global Regulatory Expansion — navigate variation classifications, lifecycle obligations, and diverging expectations across EMA, FDA, PMDA, and emerging markets

Industry Trends, Pain Points & Critical Issues

• Regulatory Deficiency Rates Remain High — CMC and analytical deficiencies continue to be the leading cause of submission delays and approval setbacks for ATMPs and biologics
• Potency Assay Gaps Remain a Leading CMC Deficiency — many ATMP and gene therapy programs still lack well-characterised, MoA-linked potency assays at the time of regulatory submission
• Comparability Complexity Increasing — process changes, scale-up, and CDMO transitions generate growing comparability obligations, yet many organisations lack structured frameworks
• Scientific Advice Underutilised — many organisations request scientific advice too late, with insufficiently targeted questions, missing the opportunity to de-risk development
• Novel Modalities Outpacing Analytical Standards — mRNA/LNP, non-viral vectors, and engineered cell therapies require characterisation approaches that regulatory agencies are still developing guidance on
• Global Regulatory Divergence — alignment between EMA, FDA, PMDA, and other agencies on ATMP requirements remains incomplete, creating planning challenges for global programs

What to Expect

• Expert-Led Workshop-Style Presentations — learn from assessors, regulatory strategists, CMC directors, and analytical leads through structured sessions designed for active engagement, not passive listening
• Practical Deep Dives & Case Studies — work through real-world scenarios: reviewing Module 3 excerpts as an assessor, building a CQA risk-ranking matrix, and mapping CMC-regulatory alignment gaps
• Interactive Panel Discussion — Practical Challenges in CMC: What Would You Do Differently?
• Live Expert Q&A & Downloadable Resources — take home post-webinar materials 

Join Us

The ATMP CMC: Regulatory Strategy, Analytics & Commercialization | Advanced Therapies Workshops 2026 is the premier platform for regulatory and analytical intelligence in ATMP and gene therapy development. If you are working to advance, characterise, approve, or commercialise an ATMP or biologics program, this workshop will deliver the regulatory insight, analytical frameworks, and expert perspectives essential for success. Secure your place at #EGeneCell 2026 and be part of the community building the next generation of approved advanced therapies.