-
1
-
-
85046471887
-
Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products
-
European Commission Union 15.9.2009. L242/3-12
-
European Commission (2009). Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products. Official Journal of the European Union 15.9.2009. L242/3-12.
-
(2009)
Official Journal of the European
-
-
-
2
-
-
85046417223
-
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
-
European Parliament and Council Union 10.12.2007. L324/121-137
-
European Parliament and Council (2007). 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. Official Journal of the European Union 10.12.2007. L324/121-137.
-
(2007)
Official Journal of the European
-
-
-
3
-
-
85206955698
-
-
European Medicines Agency
-
European Medicines Agency (2012). Certification procedure for SMEs 〈http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/ general-content-000300.jsp&mid=WC0b01ac058007f4bd〉.
-
(2012)
Certification Procedure for SMEs
-
-
-
4
-
-
84857699126
-
-
European Medicines Agency
-
European Medicines Agency (2012). Scientific advice and protocol assistance 〈http://www.ema.europa. eu/ema/index.jsp?curl=pages/regulation/ general/general-content-000049.jsp&mid=WC0b01ac058002 29b9&jsenabled= true〉.
-
(2012)
Scientific Advice and Protocol Assistance
-
-
-
5
-
-
55349105870
-
Typical pitfalls in applications for marketing authorization of biotechnological products in Europe
-
Schneider, CK and Schäffner-Dallmann, G (2008). Typical pitfalls in applications for marketing authorization of biotechnological products in Europe. Nat Rev Drug Discov 7: 893-899.
-
(2008)
Nat Rev Drug Discov
, vol.7
, pp. 893-899
-
-
Schneider, C.K.1
Schäffner-Dallmann, G.2
-
6
-
-
77649194372
-
Challenges with advanced therapy medicinal products and how to meet them
-
Committee for Advanced Therapies (CAT); CAT Scientific Secretariat
-
Committee for Advanced Therapies (CAT); CAT Scientific Secretariat, Schneider, CK, Salmikangas, P, Jilma, B, Flamion, B, Todorova, LR, Paphitou, A 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
Flamion, B.4
Todorova, L.R.5
Paphitou, A.6
-
7
-
-
85206956181
-
Commission Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
-
European Commission Union 1.5.2001. L121/34-44
-
European Commission (2001). Commission Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European Union 1.5.2001. L121/34-44.
-
(2001)
Official Journal of the European
-
-
-
8
-
-
35148813027
-
European regulation tackles tissue engineering [6]
-
DOI 10.1038/nbt1007-1089, PII NBT10071089
-
Sanzenbacher, R, Dwenger, A, Schuessler-Lenz, M, Cichutek, K and Flory, E (2007). European regulation tackles tissue engineering. Nat Biotechnol 25: 1089-1091. (Pubitemid 47538102)
-
(2007)
Nature Biotechnology
, vol.25
, Issue.10
, pp. 1089-1091
-
-
Sanzenbacher, R.1
Dwenger, A.2
Schuessler-Lenz, M.3
Cichutek, K.4
Flory, E.5
-
9
-
-
77956045297
-
Use of unregulated stemcell based medicinal products
-
Committee for Advanced Therapies (CAT) and CAT Scientific Secretariat
-
Committee for Advanced Therapies (CAT) and CAT Scientific Secretariat (2010). Use of unregulated stemcell based medicinal products. Lancet 376: 514.
-
(2010)
Lancet
, vol.376
, pp. 514
-
-
-
10
-
-
2942735008
-
Comparison of different isolation techniques prior gene expression profiling of blood derived cells: Impact on physiological responses, on overall expression and the role of different cell types
-
DOI 10.1038/sj.tpj.6500240
-
Debey, S, Schoenbeck, U, Hellmich, M, Gathof, BS, Pillai, R, Zander, T et al. (2004). Comparison of different isolation techniques prior gene expression profiling of blood derived cells: impact on physiological responses, on overall expression and the role of different cell types. Pharmacogenomics J 4: 193-207. (Pubitemid 38786558)
-
(2004)
Pharmacogenomics Journal
, vol.4
, Issue.3
, pp. 193-207
-
-
Debey, S.1
Schoenbeck, U.2
Hellmich, M.3
Gathof, B.S.4
Pillai, R.5
Zander, T.6
Schultze, J.L.7
-
11
-
-
85206956180
-
-
European Medicines Agency
-
European Medicines Agency (2010). Committee for Advanced Therapies (CAT) Work Programme 2010-2015 〈http://www.ema.europa.eu/docs/en-GB/document- library/Work-programme/2010/11/WC500099029.pdf〉.
-
(2010)
Committee for Advanced Therapies (CAT) Work Programme
, pp. 2010-2015
-
-
-
12
-
-
76949104143
-
Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency
-
Regnstrom, J, Koenig, F, Aronsson, B, Reimer, T, Svendsen, K, Tsigkos, S et al. (2010). Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency. Eur J Clin Pharmacol 66: 39-48.
-
(2010)
Eur J Clin Pharmacol
, vol.66
, pp. 39-48
-
-
Regnstrom, J.1
Koenig, F.2
Aronsson, B.3
Reimer, T.4
Svendsen, K.5
Tsigkos, S.6
-
13
-
-
81855224611
-
Stem-cell pioneer bows out
-
Baker, M (2011). Stem-cell pioneer bows out. Nature 479: 459.
-
(2011)
Nature
, vol.479
, pp. 459
-
-
Baker, M.1
-
16
-
-
85206958576
-
-
European Medicines Agency 2012
-
European Medicines Agency (2012). ATMP classification 〈http://www.ema.europa.eu/ema/index. jsp?curl=pages/regulation/general/ general-content-000296.jsp&mid=WC0b01ac058007f4bc〉 (2012).
-
(2012)
ATMP Classification
-
-
|