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Thursday, November 21 • 1:35pm - 1:55pm
The Common Threads Across All Sample Types. Challenges of Sample Management Quality and Compliance- A Perspective on Biological Licensing Compliance Activities in GSK Pharma R&D

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Innovation and performance in the pharmaceutical industry is increasingly dependent on collaborations, partnerships and access to state of art technologies and materials. At GSK, biological materials and technologies are acquired from commercial vendors, collaborators, academic and governmental institutions. These materials and technologies are always accompanied by contracts, that set the limits of the receiving and providing party rights, in a variety of forms such as general terms and conditions (T&Cs), Materials Transfer Agreements (MTAs), Limited Use Label Licenses (LULLs), Patent or know-how licenses and many more. The cost of non-compliance with terms set in these agreements could be legal, financial and reputational. Therefore, it is of paramount importance that externally-facing companies have the right processes in place to monitor which materials enter into their organization, under which terms and to ensure compliance with the contractual restrictions set by the providing third party.

Compliance to biological licenses is an emerging topic and is gaining more visibility since the entry into force in October 2014 of the Nagoya protocol. The aim of this talk will be to share some of the best practices implemented in GSK pharma R&D in order to mitigate the risk associated with Biological licenses including Access and Benefit Sharing (ABS) under the Nagoya Protocol.


Nadia Tournier

Biological Licensing Coord, GSK
Nadia completed her Master in Biotechnology at the Ecole National Superieure de Technologie des Biomolecules de Bordeaux (ENSTBB, France). She joined GSK (Stevenage, UK) in 2006 and focussed her career in Biopharmaceutical discovery with an emphasis on characterization of Antibodies... Read More →


Sue Crimmin

Vice President Sample Management Technology, GlaxoSmithKline

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Hamilton Storage

Hamilton Storage
Hamilton Company specializes in the development, manufacturing and customization of precision measurement devices, automated liquid handling workstations, and sample management systems. Hamilton's processes are optimized for quality and flexibility. Whether it's a custom needle with... Read More →

Thursday November 21, 2019 1:35pm - 1:55pm EST
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

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