Meet the training leaders
- Matthias Renner
- Head of Section Non-viral Gene Transfer Medicinal Products, Senior Scientific Assessor for quality and non-clinical aspects of ATMPs
- Paul-Ehrlich-Institut (PEI), Germany
With the increasing complexity of new cell & gene therapies, as well as a rapid growth of these products in the development, unique challenges have emerged especially in the area of manufacturing and control. Leading biotech players are utilizing available regulatory pathways to accelerate the approval of ATMPs. However, the pathways to meeting CMC requirements are not as clearly defined. Novel approaches must be taken to ensure the identity, strength, quality, purity or potency of the product.
This unique course provides a practical & in-depth understanding of CMC & quality requirements and brings clarifications on global regulation, requirements, compliance & quality concerns. Join us & achieve CMC readiness for your cell & gene therapy medicinal products.
Process validation requirements
Method validation/qualification strategies
Release specifications for ATMPs
Analytical characterization & comparability
Data requirements for manufacture and control
Gene therapy product class specificities
Manufacturing process changes/ Change control