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Retricted access

Research article

First published 2010-5

Regulatory enablers and regulatory challenges for the development of tissue-engineered products in the EU

Laure Brévignon-Dodin

Bio-Medical Materials and Engineering

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Research article

First published 2010-2

Toward a European harmonisation of the requirements for the first clinical use of Advanced Therapy Medicinal Products (ATMPs): Preclinical requirements for cell based medicinal products

Giovanni Migliaccio, Cintia Carella

Pharmaceuticals Policy and Law

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Research article

First published 2010-2

Advanced therapies: Critical points and perspectives

Christian K. Schneider

Pharmaceuticals Policy and Law

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Review article

First published 2017-09

Clinical Development and Commercialization of Advanced Therapy Medicinal Products in the European Union: How Are the Product Pipeline and Regulatory Framework Evolving?

Tomáš Boráň, Margarida Menezes-Ferreira, Ilona Reischl [...]

Human Gene Therapy Clinical Development

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Article commentary

First published 2021-10

Call for More Effective Regulation of Clinical Trials with Advanced Therapy Medicinal Products Consisting of or Containing Genetically Modified Organisms in the European Union

Alliance for Regenerative Medicine (ARM), European Federation of Pharmaceutical Industries and Associations (EFPIA), European Association for Bioindustries (EuropaBio) [...]

Human Gene Therapy

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Research article

First published 2010-2

Advanced Therapy: Rules and experiences of the Phase I Italian Competent Authority

Annarita Meneguz

Pharmaceuticals Policy and Law

Open access

Review article

First published 2021

Bringing Advanced Therapy Medicinal Products (ATMPs) for Parkinson’s Disease to the Clinic: The Investigator’s Perspective

Roger A. Barker, Emma V. Cutting, Danielle M. Daft

Journal of Parkinson’s Disease

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Review article

First published 2018-04

Advanced Therapy Medicinal Products: A Guide for Bone Marrow-derived MSC Application in Bone and Cartilage Tissue Engineering

Davide Confalonieri, Andrea Schwab, Heike Walles [...]

Tissue Engineering Part B: Reviews

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Research article

First published 2017-1

European regulation for therapeutic use of stem cells

Nicolas Ferry

Bio-Medical Materials and Engineering

Open access

Review article

First published 2017-08

A Guide to Approaching Regulatory Considerations for Lentiviral-Mediated Gene Therapies

Michael White, Roger Whittaker, Carolina Gándara [...]

Human Gene Therapy Methods (Part B)

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