TRAINING
Cell & Gene Therapy Products – CMC & Quality Requirements
9- 10 June 2020
Vienna, Austria
Now also available via online live-stream!
All sessions of this unique course online
Live interaction options between the delegates and trainer
Available via mobile, tablet or laptop
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
- Robert Zoubek
- Senior Consultant
- Granzer Regulatory Consulting & Services, Germany
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
Contact us
- Andrea Weber
- Sr. Manager for Pharma
- Phone: +421 257 272 232
- Email: event.inquiries@fleming.events