| Autor: |
Pizevska, Maja, Kaeda, Jaspal, Fritsche, Enrico, Elazaly, Hisham, Reinke, Petra, Amini, Leila |
| Rok vydání: |
2022 |
| Předmět: |
|
| DOI: |
10.17169/refubium-35786 |
| Popis: |
Advanced Therapy Medicinal Products (ATMPs) comprising cell, gene, and tissue-engineered therapies have demonstrated enormous therapeutic benefits. However, their development is complex to be managed efficiently within currently existing regulatory frameworks. Legislation and regulation requirements for ATMPs must strike a balance between the patient safety while promoting innovations to optimize exploitation of these novel therapeutics. This paradox highlights the importance of on-going dynamic dialogue between all stakeholders and regulatory science to facilitate the development of pragmatic ATMP regulatory guidelines. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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