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Online Training Features

All sessions of this unique course online

Live interaction options between the delegates and trainer

Available via mobile, tablet or laptop

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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
Learn more about the trainer
  • Robert Zoubek
  • Senior Consultant
  • Granzer Regulatory Consulting & Services, Germany
Learn more about the trainer

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.

Key topics

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

Get critical insights into ATMP classification

Familiarize yourself with specific EMA & FDA guidelines for cell & gene therapy medicinal products

Understand the interpretation of new guidelines & guidance documents

Learn how to establish comparability for complex cell & gene products

Gain clarifications on how to qualify and validate critical assays for ATMPs

Get tips for establishing CQA, CPP and KPP for cell & gene products

Explore the quality requirements for raw & starting materials

Get examples on how to apply the principles for continuous manufacturing

Gain insights into viral vector manufacturing platforms

Special considerations for release of a product having a very small volume

Understand aseptic process validation

Explore data requirements for manufacture & control

Learn how to manage change control

Understand the specifications of microbiological control

Ticket

Delegate Fee

from 1396 € Buy

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