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DIA Direct: Advanced Therapy Medicinal Product Development in Europe- On-Demand

Navigating Europe’s Regulatory Landscape for Advanced Therapies Webinar Hosted by DIA’s Advanced Therapy Community

概要

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. .

特集トピック

    • Overview of recent EMA guideline and insights into regulatory framework
    • Combination Product and Companion diagnostic considerations for ATMPs
    • EU Combine Project
    • Global Harmonization efforts

参加対象

The webinar is designed for anyone interested in learning about regulatory and scientific expectations for ATMPs in Europe and new programs that enable development.

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