00000nam 2200000zi 4500 9.931618 CaOODSP 20240228091446 m o d f cr mn||||||||| 231219s2008 quc o f000 0 eng d CaOODSP eng rda CaOODSP n-cn--- H14-474/2008E-PDF Consultation on the regulatory framework for subsequent entry biologics : summary report, June 5-6, 2008, Chateau Cartier, Aylmer, Quebec / Health Canada, Centre for Policy and Regulatory Affairs, Biologic and Genetic Therapies Directorate. Health Canada – Consultation on the Regulatory Framework for Subsequent Entry Biologics (June 5 – 6, 2008) Aylmer, Quebec : Health Canada = Santé Canada, 2008. 1 online resource (22 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Cover title. Issued 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). "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. Canada. Health Canada Public opinion. Biologicals Canada Public opinion. Public opinion Canada. Canada. Health Canada, issuing body. Consultation sur le Cadre de réglementation des produits biologiques ultérieurs : (CaOODSP)9.934524 PDF 275 KB https://publications.gc.ca/collections/collection_2024/sc-hc/H14-474-2008-eng.pdf HTML N/A https://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