Este evento pode ser de interesse para os estatisticos que atuam em centros de bioequivalência ou consultoria para as big pharmas.
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Data: Tue, 26 Jan 2010 07:45:42 -0500
De: "Nancy Chang" <nancy.chang@cvg.ca> Responder a: "Nancy Chang" <nancy.chang@cvg.ca> Para: "edson@fmrp.usp.br" <edson@fmrp.usp.br> Assunto: 4th Regulated Bioanalysis Workshop - April 2010, Montreal, Canada |
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| Dear Colleague, In continuation of 2007 - 2009 workshops, the 4th Regulated Bioanalysis Workshop (Montreal April 21-23 2010) will discuss Global Harmonization of Bioanalytical Method Validation (BMV) and sample analysis Guidelines with 5 major Worldwide Regulatory Agencies: US FDA, UK MHRA, Brazil ANVISA, Europe EMEA, and Health Canada . The main purpose of this must-attend- event is to Discuss, Review, Share Perspectives, Provide Potential Solutions and Agree upon a Consistent Approach on the Recent Issues in Regulated Bioanalysis. Detailed information can be found at http://www.canadianlcmsgroup.com/bioanalysis_glp_events.php 2010 CONTRIBUTING SPEAKERS Regulatory Bodies Brian Booth - U.S.A. FDA Louise Mawer - U.K. MHRA Kelen Carine Costa Soares - Brazil ANVISA Jan Welink - Europe EMEA representative / Dutch Medicines Evaluation Board (TBC) Health Canada TPD - participation confirmed - speaker TBC Pharmas Peter Van Amsterdam - Solvay Pharmaceuticals / EBF Surendra Bansal - Hoffmann-La Roche Christopher Evans - GlaxoSmithKline Mohammed Jamal - Bristol-Myers Squibb Joseph Marini - Johnson&Johnson Eric Wolf - Merck CROs Chris Beaver - MDS Pharma Services Marc Lefebvre - Algorithme Pharma Steve Lowes - Advion BioServices Robert Masse - Anapharm/PharmaNet Mario Rocci - ICON POSTER SUBMISSION is now OPEN. Submit your poster online at http://www.canadianlcmsgroup.com/bioanalysis_2010posters.php. 2009 WHITE PAPER was shared with regulatory Agencies and published on Bioanalysis Journal. View 2009 white paper at http://www.future-science.com/doi/abs/10.4155/bio.09.134. 2 Pre-Workshop short courses have been specifically designed to be offered prior to the workshop to prepare the attendees to fully benefit from this workshop. Short Course 1 (half day): Fundamental of Bioanalysis: Bioanalytical Method Validation (BMV) and Sample Analysis for Chromatographic and Ligand Binding Assays. Short Course 2 (full day): Regulated Bioanalysis: Challenges Solutions and Applications. *If you found this information valuable, please forward it to your colleagues. | |