Advanced Therapy Medicinal Products: An Evolving Regulatory Landscape

Posted 28 February 2017 By Patricia Hurley, PhD, Sarah Jurmeister, PhD, Kathryn Parsley, PhD

placeholder+image This article was developed from a presentation at RAPS Regulatory Convergence in September 2016 in San Jose, California, US. It was the opening presentation in the "Global Developments in Cell and Gene Therapy" session and covered introductory Advanced Therapy Medicinal Product (ATMP) concepts from definitions to strategic considerations and challenges currently faced by developers in this field.

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Categories: Biologics and biotechnology, Human cell and tissue, Regulatory strategy, Features, US, Europe, FDA, EMA

Tags: Advanced Therapies, ATMP

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