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All sessions of this unique course online

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Meet the training leader

  • 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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  • Robert Zoubek
  • Senior Consultant
  • Granzer Regulatory Consulting & Services, Germany
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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 in Vienna and 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

Special Features

Interactive learning approaches

Tailored case studies

Group exercise on Comparability principless

Individual case-by-case consultancy with the trainer

Comprehensive printed and digital course documentation

Certificate of completion issued by the trainer

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

Join us in Vienna

Vienna, also described as Europe's cultural capital, is a metropolis with unique charm, vibrancy and flair. It boasts outstanding infrastructure, is clean and safe, and has all the inspiration that you could wish for in order to discover this wonderful part of Europe.

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from 1198 € Buy

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