Cell & Gene Therapy Products – CMC & Quality Requirements

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Online Live Stream | Fleming

Cell & Gene Therapy Products – CMC & Quality Requirements

online live

Training features

Fully online

All sessions of this unique course online

Live interaction

Live interaction options between the delegates and trainer

On any device

Available via mobile, tablet or laptop

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
Principal 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
training

Brochure

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Cell and Gene Therapy Products CMC and Quality Requirements_Agenda Sneak Peek
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key training

Topics

The ATMP regulatory framework

Quality raw materials & starting materials criteria

Process development & manufacturing strategy

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

Benefits of attending

Registration

Training tickets

Delegate Fee
FROM
2496
Online Live Stream
FROM
1496

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