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.
Speakers include:
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
To view the complete programme, speakers and topics visit http://www.pharmaqbdforum.com
For all press enquiries, email sarah.brzezicki@wtgevents.com or telephone +44(0)207-202-7727.
Link:
Understand the Lessons Learned from the FDA QbD Pilot Programme - Case Study Merck Serono
Recommendation and review posted by G. Smith
