Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

How is Example 4 regulated in Europe?

A. Medical Device? B. Combined ATMP? C. Somatic cell therapy? D. Tissue engineering product?

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Key challenges with ATMPs and combined ATMPs

• Classification is critical • Donation, procurement and traceability of living cells • CQAs and Product characterisation • Identity • Purity • Potency

TOPRA MSc Module 18: Drug Device Combinations and other Technology

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