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Thursday, November 21 • 2:15pm - 2:35pm
The Common Threads Across All Sample Types. Challenges of Sample Management Quality and Compliance- Advocating Change: One Synthetic Cannabinoid at a Time

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Pharmaceutical companies routinely work with controlled substances, narcotics and psychotropic drugs, and must have controls in place to meet the legislative requirements. Today these organisations hold and dispense tens of millions of samples in highly automated processes making manual compliance activities impractical.

In 2016 the UK government amended the 1971 Misuse of Drugs Act and added a section designed to control the newer synthetic cannabinoids in increasing supply on the black market. Unfortunately, the definition was drawn extremely broadly.
The impact of this amendment is that typical Pharmaceutical libraries have seen their controlled compounds rise into the tens of thousands, with the clear majority having no indication of CB1 activity. This has prevented early discovery activities and limited collaborative research due to the inability to ship these compounds outside the UK. Many existing products like Atorvastatin (Lipitor – Pfizer, statin) and Lostartan (Cozaar – Merck & Co, Angiotensin) are also affected. Not only are these proven medicines, and so do not fall into Schedule 1, which is specifically for substances considered by the government to have no medicinal value, but they also do not exhibit any cannabinoid-like activity

This talk covers the needs for software packages to identify controlled substances and how the Controlled Substance Compliance Expert Community (Pistoia Alliance) is working with the UK’s Advisory Council for the Misuse of Drugs by providing expertise to narrow the scope of the definition and suggest other measures such as de-minimis limits and research exemptions which should lead to an amendment of the law

Speakers
avatar for Zofia Jordon

Zofia Jordon

Chair of the Controlled Substance Expert Group, Pistoia Alliance
Chair, Controlled Substance Expert Group (Pistoia Alliance) The group shares best practice, learns from external experts and collaborates to improve understanding of current issues in controlled substance legislation and is part of the Pistoia Alliance, a global, not-for-profit members... Read More →

Chairs
SC

Sue Crimmin

Vice President Sample Management Technology, GlaxoSmithKline

Sponsors
avatar for Hamilton Storage

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 2:15pm - 2:35pm EST
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

Attendees (1)