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ADAPTIVE LICENSING FOR ATMPS
Session Chair(s)
Hans Ovelgoenne
Medicines Evaluation Board, Netherlands
In March 2014 the EMA launched a pilot project into adaptive pathways. The aim was to investigate a better use of real-world data in the licensing of medicinal products, in conjunction with HTAs. Several companies submitted products into this pilot, including a larger than expected proportion of ATMPs. What is special about ATMPs?
Speaker(s)
ATMPs and the EMA Pilot Project on Adaptive Pathways
Hans Ovelgoenne
Medicines Evaluation Board, Netherlands
How to Meet Post-Marketing Obligations?
Maria Pascual, PHARMD
EBE-EFPIA, Spain
Chair of Advanced Therapies Working Group