November, 2024
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Dominika Misztela: Econ Cell and Gene Therapy Summit – Day 1 highlight
Apr 18, 2024, 16:53

Dominika Misztela: Econ Cell and Gene Therapy Summit – Day 1 highlight

Dominika Misztela, Director of Global Regulatory Affairs Science, Policy, and Intelligence of CSL Brussels Metropolitan Area, shared a post on LinkedIn:

Econ Cell Gene Therapy Summit – Day 1 highlight.

Some key takeaway points, including from Karen Pinachyan:

  •  Revised Pharma Package promising valuable progress: platform technology, adaptive pathways, reduced review timelines, simplified EMA committee structure, and provisions for decentralised manufacturing
  •  Regulatory harmonisation, including EU, GMO, and clear and consistent regulatory advice and assessment
  • Appropriate use of patient data in view of GDPR and EHDS – especially as patient populations are so small
  • Access frameworks that reflect the specific nature of ATMPs for developers and manufacturers of these therapies in the EU.

Source: Dominika Misztela/LinkedIn


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