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...: H14-474/2008E-PDF
"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.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.931618&sl=0
Department/Agency | Canada. Health Canada, issuing body. |
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Title | 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. |
Variant title | Health Canada – Consultation on the Regulatory Framework for Subsequent Entry Biologics (June 5 – 6, 2008) |
Publication type | Monograph |
Language | [English] |
Other language editions | [French] |
Format | Electronic |
Electronic document | |
Note(s) | 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). |
Publishing information | Aylmer, Quebec : Health Canada = Santé Canada, 2008. |
Description | 1 online resource (22 pages) |
Catalogue number |
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Subject terms | Canada. Health Canada -- Public opinion. Biologicals -- Canada -- Public opinion. Public opinion -- Canada. |