Cell and Gene Therapy Training Courses

• Trainer Expertise — Our instructors bring deep, hands-on experience from cell & gene therapy R&D, CMC development, analytics and more. All have worked with small start-up companies, large pharma and regulators.
• Practical Focus — Through real case studies, interactive workshops, and project scenarios, you’ll learn how to translate advanced science into compliant development and regulatory strategies.
• Global Regulatory Coverage — Courses integrate content on ATMP / CGT regulation in the EU and FDA / US.
• Post-Learning Support — Access reinforcement materials, learning reference guides, regulatory updates, and continuous support to help you embed learning in live projects.
• Flexible Delivery Formats — Choose from live online, hybrid, classroom or on-demand delivery modes tailored to individual learners or team training.

In our ATMP portfolio topics include:

• CGT regulatory frameworks: EMA ATMP regulation, FDA gene & cell therapy guidances, UK / EU
• Viral vector and non-viral delivery systems (AAV, lentivirus, CRISPR, gene editing)
• Cell processing, engineering, expansion, differentiation & purification
• Quality control, potency assays, characterization, comparability
• Process development, scale-up, tech transfer & GMP manufacturing
• Safety, biodistribution, long-term follow up & immunogenicity
• Clinical development, patient follow-up, durability, endpoints
• Risk management, biosafety, vector shedding, transgene integration
• Post-market surveillance, changes & lifecycle management

Our training courses are ideal for:

• Regulatory affairs, quality, and compliance professionals in CGT / ATMP organisations
• Process development, bioprocess engineers, vector scientists
• Analytical, assay development and QC teams
• Clinical / translational staff working with cell or gene therapy trials
• Startups, research institutions, biotech firms developing ATMPs

Comprehensive Cell & Gene Therapy Training for Advanced Developers

The development of cell and gene therapies requires a deep understanding of both cutting-edge science and evolving regulatory frameworks. Our training programmes span vector design, manufacturing, regulatory strategy, clinical development, and lifecycle management. We cover regulatory expectations such as EMA ATMP regulation, FDA gene & cell therapy guidances, and global harmonisation trends.

Vector Development & Manufacturing Strategy

Learn the nuances of viral (AAV, lentivirus) and non-viral gene delivery systems, cell engineering, expansion, purification, and downstream processing. Explore how to develop manufacturing strategies, scale processes, and manage comparability and control for ATMPs.

Safety, Clinical Strategy & Long-Term Follow-Up

Because CGT products often require long-term monitoring, we emphasize topics like biodistribution, transgene integration, immunogenicity, vector shedding, durability, and safety follow-up. You’ll also explore how to design clinical endpoints, manage follow-up studies, and align with agency expectations.

Regulatory Strategy & Lifecycle Management

Address regulatory pathways (IMPD, BLA, MAA for ATMPs), expedited designations, post-approval changes, and regulatory reporting obligations. Understand how to evolve your strategy as the product moves from preclinical through late clinical to commercial lifecycle.