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EMEA and FDA focus on clinical research safety and enforcement

McDermott Will & Emery
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European Union, USA
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August 20 2009

Recent policy changes emphasize the need for sponsoring organizations to be even more vigilant in establishing, updating and monitoring their systems for compliance with clinical research requirements, whether conducted domestically or in a foreign locale

Product and disease registries: planning for data protection

McDermott Will & Emery
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European Union, USA
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April 10 2007

Biopharmaceutical companies have now seen the power of post-market approval and observational registries

UK Supreme Court steps into line with Europe, but rejects U.S. approach

McDermott Will & Emery
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European Union, United Kingdom, USA
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November 30 2011

The UK’s highest court recently considered the provisions of the European Patent Convention (EPC) centering on the “susceptible of industrial application” requirement in the context of a patent describing a DNA sequence for a new protein, Neutrokine-α, which was a member of a group of similar proteins known as the TNF ligand superfamily

Navigating the evolving regulation and commercialization of stem cell research

McDermott Will & Emery
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European Union, USA
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March 22 2012

Interested parties that can successfully navigate the evolving regulation of stem cell research stand to gain significant scientific and commercial advantage

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EMEA and FDA focus on clinical research safety and enforcement

Product and disease registries: planning for data protection

UK Supreme Court steps into line with Europe, but rejects U.S. approach

Navigating the evolving regulation and commercialization of stem cell research

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