Advanced Therapy Medicinal Product Development in Europe

Keyword(s) AI in clinical trials, artificial intelligence, regulated products, ethical AI

Tag(s) Good Clinical Practices & QA, Clinical Development & Operations, Artificial Intelligence (AI)

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Description

Join DIA’s Advanced Therapy Community for this upcoming webinar. 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.

Join us on Wednesday, July 23rd from 9:00am-10:00am for this live DIA Direct Webinar.

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