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Time is TBD
|Location is TBD
ATMP: from Basics to Regulatory Approval
ATMPs are very promising therapies, but their scientific and regulatory journey is rather long. Be prepared and well-trained to be successful!
Time & Location
Time is TBD
Location is TBD
About the training
This training is customised on client needs. Our trainers are well-recognised ATMPs developers professionals at the different stage of the ATMP value chain.
Some content examples are:
- ATMPs basics: Science to Regulation, New technologies in ATMPs development, production and evaluation.
- Preclinical studies: Good Cell Culture Practice – GCCP, Advanced in vitro models, Advanced GCCP.
- Good Manufacturing Practices : GMP for ATMPs, Case study: CAR-T cell production, GMP viral particle production for gene therapy.
- ATMP markets and management : Market overview, Market access strategies, Ethics and commercial exploitation, ATMPs facility quality management, ATMPs facility economic-financial sustainability
- Regulatory affairs : Immunogenicity testing for ATMPs, European Regulatory Framework for an ATMP, Regulation: EU vs FDA, Interactions with Regulatory Agencies, such as Classification of ATMPs, Scientific Advice procedures, PRIME SCHEME, Case studies, ATMPs dossier specifications, Regulatory CMC, Hospital exemption, Orphan designation.
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