Cell and Gene Therapies: European View on Challenges in Translation and How to Address Them

Author:

Rousseau Cécile F.,Mačiulaitis Romaldas,Śladowski Dariusz,Narayanan Gopalan

Publisher

Frontiers Media SA

Subject

General Medicine

Reference17 articles.

1. Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on Advanced Therapy Medicinal Products and Amending Directive 2001/83/EC and Regulation (EC) No 726/2004

2. Clinical development of advanced therapy medicinal products in Europe: evidence that regulators must be proactive;Maciulaitis;Mol Ther.,2012

3. Clinical development and commercialization of advanced therapy medicinal products in the European union: how are the product pipeline and regulatory framework evolving?;Borán;Hum Gene Ther Clin Dev.,2017

4. EMA Guidelines Relevant for Advanced Therapy Medicinal Products

5. Directive 2004/23/EC of the European Parliament And of the Council of 31 March 2004 on Setting Standards of Quality and Safety for the Donation Procurement Testing Processing Preservation Storage and Distribution of Human Tissues and Cells

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