Cell & Gene Therapy Products – CMC & Quality Requirements

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Cell & Gene Therapy Products – CMC & Quality Requirements

online live

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Fully online

All sessions of this unique course online

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Course description

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.

meet the training leaders
Robert E. Zoubek
Senior Consultant
Granzer Regulatory Consulting & Services, Germany
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
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Cell & Gene Therapy Products – CMC & Quality Requirements Training Course | Fleming
Cell & Gene Therapy Products – CMC & Quality Requirements Training Course | Fleming
Cell & Gene Therapy Products – CMC & Quality Requirements Training Course | Fleming
key training

Topics

The ATMP regulatory framework

Quality raw materials & starting materials criteria

Process development & manufacturing strategy

Process validation requirements

Analytical characterization & comparability

Data requirements for manufacture and control

Gene therapy product class specificities

Method validation/qualification strategies

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