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.
Lien permanent pour cette publication :
publications.gc.ca/pub?id=9.931618&sl=1
| Ministère/Organisme | Canada. Health Canada, issuing body. |
|---|---|
| Titre | 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. |
| Variante du titre | Health Canada – Consultation on the Regulatory Framework for Subsequent Entry Biologics (June 5 – 6, 2008) |
| Type de publication | Monographie |
| Langue | [Anglais] |
| Autres langues publiées | [Français] |
| Format | Électronique |
| Document électronique | |
| 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). |
| Information sur la publication | Aylmer, Quebec : Health Canada = Santé Canada, 2008. |
| Description | 1 online resource (22 pages) |
| Numéro de catalogue |
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| Descripteurs | Canada. Health Canada -- Public opinion. Biologicals -- Canada -- Public opinion. Public opinion -- Canada. |