The team discuss the latest update on the proposed EU health technology assessment (HTA) regulation. The key objectives of the 2018 proposal was to promote convergence in HTA tools, procedures and methodologies; reduce duplication of efforts for HTA bodies and industry and improve joint use of outputs. This episode goes indepth into the one of the controversial aspects of the proposal - The joint clinical assessment - that caused a near stand still in negotiations between member states.
Presenter: Christina Poschen
Contributor: Ciaran Cassidy
Producer: Aparna Krishnan
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Celebrating 5 Years of P4A: Reflections on Rare Diseases, Cell and Gene Therapies, and Legislation in Europe
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Navigating the New EU HTA Regulation and Its Impact on ATMP Development
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China market access: obstacle or opportunity for orphan drug, cell and gene therapy manufacturers?
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