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Volumn 24, Issue 1, 2013, Pages 12-18

A comprehensive resource on EU regulatory information for investigators in gene therapy clinical research and advanced therapy medicinal products

Author keywords

[No Author keywords available]

Indexed keywords

NUCLEIC ACID; RECOMBINANT NUCLEIC ACID; UNCLASSIFIED DRUG;

EID: 84872778533     PISSN: 10430342     EISSN: 15577422     Source Type: Journal    
DOI: 10.1089/hum.2012.2525     Document Type: Review
Times cited : (8)

References (18)
  • 2
    • 84872760700 scopus 로고    scopus 로고
    • Centralised regulation of gene therapy in europe
    • O. Cohen-Haguenauer, ed. (EDK, Paris)
    • Cohen-Haguenauer, O. (2012a). Centralised regulation of gene therapy in europe. In The CliniBook: Clinical Gene Transfer State-of-the-Art. O. Cohen-Haguenauer, ed. (EDK, Paris), pp. 504-516.
    • (2012) The CliniBook: Clinical Gene Transfer State-of-the-Art , pp. 504-516
    • Cohen-Haguenauer, O.1
  • 3
    • 84872827081 scopus 로고    scopus 로고
    • The necessity for data sharing towards advancement of clinical translation; Building up sample IMPD and substantiating master files
    • O. Cohen-Haguenauer, ed. (EDK, Paris)
    • Cohen-Haguenauer, O. (2012b). The necessity for data sharing towards advancement of clinical translation; building up sample IMPD and substantiating master files. In The CliniBook: Clinical Gene Transfer State-of-the-Art. O. Cohen-Haguenauer, ed. (EDK, Paris) pp. 517-527.
    • (2012) The CliniBook: Clinical Gene Transfer State-of-the-Art , pp. 517-527
    • Cohen-Haguenauer, O.1
  • 4
    • 84861882665 scopus 로고    scopus 로고
    • Challenges in vector and trial design using retroviral vectors for long-term gene correction in hematopoietic stem cell gene therapy: Summary of a symposium sponsored by the NIH Office of biotechnology activities and the EC DG research NoE for the advancement of clinical gene transfer and therapy
    • Corrigan-Curay, J., Cohen-Haguenauer, O., O'Reilly, M., et al. (2012). Challenges in vector and trial design using retroviral vectors for long-term gene correction in hematopoietic stem cell gene therapy: summary of a symposium sponsored by the NIH Office of Biotechnology Activities and the EC DGresearch NoE for the Advancement of Clinical Gene Transfer and Therapy. Mol. Ther. 20, 1084-1094.
    • (2012) Mol. Ther. , vol.20 , pp. 1084-1094
    • Corrigan-Curay, J.1    Cohen-Haguenauer, O.2    O'reilly, M.3
  • 9
    • 84872767432 scopus 로고    scopus 로고
    • Public Health. (accessed July)
    • European Commission, DG Health and Consumers. [e] Public Health. Available at http://ec.europa.eu/health/index-en.htm (accessed July 2012).
    • (2012)
  • 10
    • 84872805060 scopus 로고    scopus 로고
    • accessed July
    • European Medicines Agency. [a] Advanced therapies. Available at www.ema.europa.eu/ema/index.jsp?curl=pages/special-topics/general/ general-content-000504.jsp&mid=WC0b01ac 058050f347 (accessed July 2012).
    • (2012) Advanced Therapies
  • 11
    • 25844468887 scopus 로고    scopus 로고
    • accessed July
    • European Medicines Agency. [b] Committee for Medicinal Products for Human Use (CHMP). Available at www.ema.europa.eu/ema/index.jsp?curl=pages/about-us/ general/general- content-000094.jsp&mid=WC0b01ac0580028c79 (accessed July 2012).
    • (2012) Committee for Medicinal Products for Human Use (CHMP)
  • 14
    • 84872790288 scopus 로고    scopus 로고
    • Regulation (EC) No 1901/ 2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/ EC, Directive 2001/83/EC and Regulation (EC) No 726/2004
    • European Parliament and Council. Regulation (EC) No 1901/ 2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/ EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. Available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:378:0001:0019: en:PDF
  • 15
    • 79951842492 scopus 로고    scopus 로고
    • Toward a proportionate regulatory framework for gene transfer: A patient group-led initiative
    • Kent, A., King, N.M., and Cohen-Haguenauer, O. (2011) Toward a proportionate regulatory framework for gene transfer: a patient group-led initiative. Hum. Gene Ther. 22, 126-134.
    • (2011) Hum. Gene Ther. , vol.22 , pp. 126-134
    • Kent, A.1    King, N.M.2    Cohen-Haguenauer, O.3
  • 16
    • 39849087852 scopus 로고    scopus 로고
    • En route to ethical recommendations for gene transfer clinical trials
    • King, N.M., and Cohen-Haguenauer, O. (2008) En route to ethical recommendations for gene transfer clinical trials. Mol. Ther. 16, 432-438.
    • (2008) Mol. Ther. , vol.16 , pp. 432-438
    • King, N.M.1    Cohen-Haguenauer, O.2
  • 18
    • 77649194372 scopus 로고    scopus 로고
    • Challenges with advanced therapy medicinal products and how to meet them
    • Schneider, C.K., Salmikangas, P., Jilma, B., et al. (2010). Challenges with advanced therapy medicinal products and how to meet them. Nat. Rev. Drug Discov. 9, 195-201.
    • (2010) Nat. Rev. Drug Discov. , vol.9 , pp. 195-201
    • Schneider, C.K.1    Salmikangas, P.2    Jilma, B.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.