Understand the Lessons Learned from the FDA QbD Pilot Programme – Case Study Merck Serono
LONDON, February 15, 2012 /PRNewswire/ –
Senior representatives from leading pharmaceutical companies including Roche
Diagnostics, Lonza, Abbott, F. Hoffman-La-Roche LTD and Novartis MIT will meet at the
Pharma Qbd Forum in Berlin, Germany on 24th-25th April 2012 to share their expert
knowledge on how Quality by Design can be implemented in pharmaceutical development.
One of the main points of discussion will be the findings of the Merck Serono case
study and how the lessons learned from this FDA Pilot Programme can shape the way for QbD
projects in Europe and abroad. This session will be led by Pascal Valax, Group Head,
Biotech Process Sciences, Merck Serono SA.
- Dr. John R Donaubauer, Director, Scientific Affairs Development Sciences Process R&D - Abbott - Dr.Richard Lakerveld, Associate - Novartis-MIT Center for Continuous Manufacturing - Serj Vartanian, Head of Global Quality Systems MBB - Baxter Healthcare Corporation - Dr. Gawayne Mahboubian-Jones, Program head - Excellence in Science and Design - Philip Morris International - Dr.Paul Stonestreet, Global Drug Substance Project Co-ordinator, Small Molecule Technical Development - F.Hoffman-La-Roche Ltd - Dr. Dirk Pamperin, VP R&D - Synthon Pharmaceuticals - Dr. Alessandro Butte, Head of DSP - Lonza - Sarah Mercier, Scientist USP - Crucell Holland BV - Dr. John Crowley, Head of Cell Culture Development - Lonza Biologics - Dr. Andreas Schneider, Vice President Life Science Alliances - Roche Diagnostics - Prof. Gary Montague, Professor of Bioprocess Control - Newcastle University - Dr. Mel Koch, Executive Director - CPAC Centre for Process and Analytical Control (University of Washington) - Prof. Mathieu Streefland, Professor Bioprocess Engineering - Wageningen University - Prof. Jose Cardoso de Menezes, Department of BioEngineering - Institute of Biotechnology & Bioengineering
Conference topics include:
- Building quality earlier in the process - Improving process understanding - Successfully defining criticality - Defining continuous verification and the expanded change protocol - Lifecycle strategies for biopharmaceutical QbD - Implementing continuous manufacturing with QbD to reduce production timelines - Translating established development practice into QbD
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