Speaking Proposals Due 17th May
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Post Conference Workshop - GMT (Greenwich Mean Time, GMTZ)
Post Conference Workshop - GMT (Greenwich Mean Time, GMTZ)
Relevant Regulatory Background in the Field of CGT and QbD
- Laws and Guidelines
- CMC requirements
- Definitions
Quality by Design (QbD) Concept and Approaches
- Gain a practical guidance to QbD
- How to apply QbD
- Step by step approach from Target Product Profile to critical process ranges
- Generation of product and process knowledge
- Learn how to link product and process characterization together
- Overview of development throughout the lifecycle
- Specificities to CGT
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
- Different Risk management methods and tools
- Learn how to assess risks and managing the risks
- Linkage studies
- Examples for Failure Mode, Effect and Criticality Analyses (FMECA)
- Case studies in the field of CGT
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
- Examining design, qualification and validation - Discover what to do and when?
- Pre-requisites to start production for clinical studies
- Product and Process development & characterization
- How to define preliminary critical quality attributes (pCQAs)
- Linkage studies of preliminary critical quality attributes (pCQAs) and preliminary critical process parameters (pCPPs)
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
- Small-scale process model definition and utilization
- Learn how to use small process models
- Statistical models
- Proven Acceptable Range studies & Design Space development
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
- Process overview
- Objectives of main processing steps
- Cell lines (generation & characterization) - regulatory requirements
- Materials and risks
- Where processing under GMP needs to start?
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
Change is inevitable and one objective of product development is to ensure sufficient product and process understanding to allow process changes to be made. Comparability is a complex concept for any biological product, and poses extra challenges for many ATMP. This workshop will cover;
- ICH Q5E principles
- New draft FDA guideline - does it change anything?
- Planning and conducting comparability studies
- Concluding if its comparable.
- Christopher Bravery, Ph.D. - Consulting Regulatory Scientist, Advbiols
Change is inevitable and one objective of product development is to ensure sufficient product and process understanding to allow process changes to be made. Comparability is a complex concept for any biological product, and poses extra challenges for many ATMP. This workshop will cover;
- ICH Q5E principles
- New draft FDA guideline - does it change anything?
- Planning and conducting comparability studies
- Concluding if its comparable.
- Christopher Bravery, Ph.D. - Consulting Regulatory Scientist, Advbiols
Change is inevitable and one objective of product development is to ensure sufficient product and process understanding to allow process changes to be made. Comparability is a complex concept for any biological product, and poses extra challenges for many ATMP. This workshop will cover;
- ICH Q5E principles
- New draft FDA guideline - does it change anything?
- Planning and conducting comparability studies
- Concluding if its comparable.
- Christopher Bravery, Ph.D. - Consulting Regulatory Scientist, Advbiols
Change is inevitable and one objective of product development is to ensure sufficient product and process understanding to allow process changes to be made. Comparability is a complex concept for any biological product, and poses extra challenges for many ATMP. This workshop will cover;
- ICH Q5E principles
- New draft FDA guideline - does it change anything?
- Planning and conducting comparability studies
- Concluding if its comparable.
- Christopher Bravery, Ph.D. - Consulting Regulatory Scientist, Advbiols