Clinical Trial Applications Notice http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/ guide-ld/clini/ctdctanotice_ctddecavis_e.html Guidance Document http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/ guide-ld/clini/ctdcta_ctddec_e.html Modification to Good Manufacturing Practices (GMP) Guidelines 2002 Edition, May 23, 2002 http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/ guide-ld-2002/index_e.html Appendix II 1.
Demandes d’essais cliniques Avis http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/ guide-ld/clini/ctdctanotice_ctddecavis_f.html Lignes directrices http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/ guide-ld/clini/ctdcta_ctddec_f.html Modification à l'édition 2002 des lignes directrices sur les bonnes pratiques de fabrication (BPF), 23 mai 2002 http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/ guide-ld-2002/index_f.html Annexe II 1.