Challenges in Advanced Therapy Medicinal Product Development: A Survey among Companies in Europe-Reference-Cited by-同舟云学术

Challenges in Advanced Therapy Medicinal Product Development: A Survey among Companies in Europe

Published:2018-12 Issue: Volume:11 Page:121-130
ISSN:2329-0501
Container-title:Molecular Therapy - Methods & Clinical Development
language:en
Short-container-title:Molecular Therapy - Methods & Clinical Development

Author:

ten Ham Renske M.T.,Hoekman Jarno,Hövels Anke M.,Broekmans Andre W.,Leufkens Hubert G.M.,Klungel Olaf H.

Funder

European Federation of Pharmaceutical Industries and AssociationsEuropean Federation of Pharmaceutical Industries and Associations

European Biopharmaceutical Enterprises

Publisher

Elsevier BV

Subject

Genetics,Molecular Biology,Molecular Medicine

Reference47 articles.

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2. 2. (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

3. 3. (EC) No 726/2004. Official Journal of the European Union, L 324/121. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:324:0121:0137:en:PDF.

4. Hidalgo-Simon, A. (2017). The EMA view: advanced therapies in Europe. https://www.ebe-biopharma.eu/wp-content/uploads/2017/12/2017-AHS-pesentation-6th-EBE-Annual-Regulatory-Conference-5-Dec-17.pdf..

5. Regulation of advanced therapy medicinal products in Europe and the role of academia;Pearce;Cytotherapy,2014

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