Controlled substances: A new challenge for life sciences industry

presentation · 5 years ago
by Aurora Costache (ChemAxon)

The increased number of controlled substances and legislations are part of the new challenges that life science industries worldwide are facing these days. Compounds which are subject to legislation for their production, import / export, supply, use, possession and disposal like narcotics, psychotropic drugs, explosives, hazardous materials, and toxic agents are known as controlled substances. Because of their negative effect on humans' health and the environment, the production and handling of these substances is highly regulated. Since companies across the industry routinely work with controlled chemicals, there is an unmet need to have an adequate system in place to verify if the compounds they produce, purchase, store, or transport, fall under any regulations described by the law. As quite often much of the R&D operations of the parent companies are being outsourced to Contract Research Organizations (CROs), often located in other countries, they have to check if their compounds satisfy the legislations of the countries where their CROs operate. For these reasons, there is an urgent need for a comprehensive system that offers the ability to readily check if substances fall under any control Compliance regulations locally, nationally or internationally. A comprehensive, robust and consistent system which helps maintain Compliance regardless of geographic location and will adapt with the rapidly changing legislation requirements is highly desirable. This will allow support not just to R&D, but other business functions such as Purchasing, Shipping, Legal and Forensics departments, as seen in Figure 1.

In this talk will be presented the capabilities of such system (Compliance Checker), a web-based application tool that allows researchers to carry out fast searches mainly by structure, against a constantly maintained, high-quality legislation database covering a wide range of geographical areas.

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Figure1: Business functions supported by Compliance Checker in a typical company dealing with chemicals