Advancing Revolutionary Therapies
Cell and gene therapies have made impressive clinical progress but continue to face big hurdles. Nothing is standard about study design, study conduct or regulatory process in this specialized area.
Advancing Revolutionary Therapies
The influence of MDR’s Article 117 in the Marketing of Combination Products
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ART
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Season 3
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Episode 9
MDR’s Article 117 brings improved patient safety measures with implications for manufacturers, as they must fulfill a significant set of additional requirements. Listen as Andrea Larrañaga, Associate Manager, Regulatory Affairs at Veristat and her colleagues, Laura Ocaña and Gemma Dorrego, discuss the Article and its influence in the marketing of combination products.