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008231219s2008    quc     o    f000 0 eng d
040 |aCaOODSP|beng|erda|cCaOODSP
043 |an-cn---
0861 |aH14-474/2008E-PDF
24500|aConsultation on the regulatory framework for subsequent entry biologics : |bsummary report, June 5-6, 2008, Chateau Cartier, Aylmer, Quebec / |cHealth Canada, Centre for Policy and Regulatory Affairs, Biologic and Genetic Therapies Directorate.
24617|aHealth Canada – Consultation on the Regulatory Framework for Subsequent Entry Biologics (June 5 – 6, 2008)
264 1|aAylmer, Quebec : |bHealth Canada = Santé Canada, |c2008.
300 |a1 online resource (22 pages)
336 |atext|btxt|2rdacontent
337 |acomputer|bc|2rdamedia
338 |aonline resource|bcr|2rdacarrier
500 |aCover title.
500 |aIssued also in French under title: Consultation sur le Cadre de réglementation des produits biologiques ultérieurs : rapport sommaire, les 5 et 6 juin 2008, Château Cartier, Aylmer (Québec).
520 |a"In twelve hours of meetings over two days in early June 2008, 105 government and stakeholder representatives enjoyed the opportunity to exchange information and views with regard to Subsequent Entry Biologic products (SEBs). A series of presentations were followed by intensive table discussions around the key issues, including fundamental concepts, quality requirements, clinical requirements, intellectual property, comparability, and post-market measures"--Consultation summary, page 3.
61010|aCanada. |bHealth Canada|xPublic opinion.
650 0|aBiologicals|zCanada|xPublic opinion.
650 0|aPublic opinion|zCanada.
7101 |aCanada. |bHealth Canada, |eissuing body.
77508|tConsultation sur le Cadre de réglementation des produits biologiques ultérieurs : |w(CaOODSP)9.934524
85640|qPDF|s275 KB|uhttps://publications.gc.ca/collections/collection_2024/sc-hc/H14-474-2008-eng.pdf
8564 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/biologics-radio-pharmaceuticals-genetic-therapies/consultation-regulatory-framework-subsequent-entry-biologics-summary-report-june-5-6-2008-health-canada.html