Follow the link to download the oral presentations program of the 2008 FABIAN meeting on "Biopharma, Biosimilar, Biogeneric? Bioanalysis!"Tuesday, October 28, 2008
FABIAN 2008 - Program
Follow the link to download the oral presentations program of the 2008 FABIAN meeting on "Biopharma, Biosimilar, Biogeneric? Bioanalysis!"Monday, October 6, 2008
FABIAN 2008 - Prelimenary Program
09:30 Registration, coffee
10:00 Welcome & Opening
10:05 Huub Schellekens, University of Utrecht
Title to be submitted
10:50 Reed Harris, Genentech Inc. South San Francisco, CA, USA
Comparability Assessment Strategies and Techniques for Post-Approval CMC Changes
11:35 Andreas Seidl, Novartis/Sandoz
Title to be submitted
12:20 Lunch & Poster session
13:15 Henno van den Hooven, Schering-Plough, Oss
Analytical assessment of biotech product quality
13:55 Claudia Berger, Solvay, Germany
Oral recombinant enzyme replacement therapy: DMPK and Immunogenicity Assessment (A Case Study)
14:35 Joseph Marini, Centocor, Radnor, PA, USA
Title to be submitted
15:15 Meena Subramanyan, Biogen Idec, Boston, MA, USA
Title to be submitted
16.00 Closure & Farewell drink
10:00 Welcome & Opening
10:05 Huub Schellekens, University of Utrecht
Title to be submitted
10:50 Reed Harris, Genentech Inc. South San Francisco, CA, USA
Comparability Assessment Strategies and Techniques for Post-Approval CMC Changes
11:35 Andreas Seidl, Novartis/Sandoz
Title to be submitted
12:20 Lunch & Poster session
13:15 Henno van den Hooven, Schering-Plough, Oss
Analytical assessment of biotech product quality
13:55 Claudia Berger, Solvay, Germany
Oral recombinant enzyme replacement therapy: DMPK and Immunogenicity Assessment (A Case Study)
14:35 Joseph Marini, Centocor, Radnor, PA, USA
Title to be submitted
15:15 Meena Subramanyan, Biogen Idec, Boston, MA, USA
Title to be submitted
16.00 Closure & Farewell drink
Friday, September 19, 2008
FABIAN 2008
6 November 2008, Rode Zaal, UMCG (AZG), GroningenFor more information go to: http://bioanalyse.org/symposia/fabian2008.htm
Tuesday, September 9, 2008
EBF Bioanalytical Conference
As announced last July the European Bioanalysis Forum is organizing her first open annual symposium which will be held in Barcelona on 1 & 2 December this year. Download the flyer and/or go directly to the conference site for more information
Wednesday, July 23, 2008
EBF Bioanalytical Conference
European Bioanalysis Forum - First Open Symposium: “Burning Issues in Bioanalysis”
The European Bioanalysis Forum is pleased to announce its first annual open meeting to be held in Barcelona on the 1st and 2nd of December 2008. The European Bioanalysis Forum (EBF) is a bioanalytical discussion group comprised of European pharmaceutical companies (24 member companies to date). The Membership shares a common vision to advance our understanding of topical concerns through discussion of scientific, technological and regulatory issues of bioanalytical interest.
More information and registration on: http://bioanalyticalconference.googlepages.com/
The European Bioanalysis Forum is pleased to announce its first annual open meeting to be held in Barcelona on the 1st and 2nd of December 2008. The European Bioanalysis Forum (EBF) is a bioanalytical discussion group comprised of European pharmaceutical companies (24 member companies to date). The Membership shares a common vision to advance our understanding of topical concerns through discussion of scientific, technological and regulatory issues of bioanalytical interest.More information and registration on: http://bioanalyticalconference.googlepages.com/
FABIAN 2008
Mark your calendars! The 2008 FABIAN symposium will be held in Groningen this year on 6 November
AAPS Crystal City III revisited
Last February the issue of Incurred Sample Reproducibility was extensively discussed at the AAPS meeting in Crystal City: AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples—Implications of Crystal City Recommendations.
Is was a good meeting albeit disappointing to learn that apperently the FDA had made up their mind prior to the meeting and that despite all the inpute from BA scientists they could not be convinced to see it differently. Most of the slides have in the mean time been made available via the AAPS website. Of special interest is of course the summary slide deck.
Is was a good meeting albeit disappointing to learn that apperently the FDA had made up their mind prior to the meeting and that despite all the inpute from BA scientists they could not be convinced to see it differently. Most of the slides have in the mean time been made available via the AAPS website. Of special interest is of course the summary slide deck.
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