Advanced Therapy Medicinal Product Development in Europe
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Keyword(s)
AI in clinical trials, artificial intelligence, regulated products, ethical AI



Description
Don't miss this on-demand webinar done in partnership with the Advanced Therapy Community. Developing an Advanced Therapy Medicinal product (cell, gene, and tissue products) can be a complex regulatory and development challenge. At this webinar, we will focus on Europe’s regulatory framework with insights on recent guidelines, programs, harmonization efforts, and development considerations for pharmaceutical/biotech manufacturers.
FEATURED TOPICS
- Overview of recent EMA guideline “Guideline on quality, non-clinical, and clinical requirements for investigational advanced therapy medicinal products in clinical trials-Scientific guideline” and insights into regulatory framework
- Combination Product and Companion Diagnostic Considerations for ATMPs
- EU Combine Project
- Global Harmonization Efforts