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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