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  • Regulatory

The Highs and Lows of Cannabinoid Research: Exploring the Regulatory, Clinical, and Bioanalytical Requirements in the US and Canada

July 11, 2018
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Wednesday, July 11, 2018 @ 10am – 11am EDT

Interest in the medical use of cannabis and cannabinoids continues to grow as patients and caregivers consider this option for treatment of unmet medical needs. Ever growing efforts to legalize cannabinoids in the US and Canada are creating an increased need to evaluate safe and effective use. Individual cannabinoids have been approved for use as appetite stimulants and anti-emetics in the US, and as an adjunct treatment for the relief of spasticity in patients with multiple sclerosis in Canada.

    Recently, a cannabidiol oral solution, for the adjunctive treatment of seizures associated with Lennox-Gastaut and Dravet syndrome, underwent a successful FDA Advisory Committee review. Cannabis plant material has been cited as potentially useful in various other conditions including glaucoma, AIDs wasting syndrome, neuropathic pain, cancer, multiple sclerosis, chemotherapy-induced nausea, and certain seizure disorders. Many indications have currently not been presented with formal studies for the review and approval of the FDA and Health Canada, and more research is needed to support the given indications. Regulatory agencies are expressing the need for adequate safety, efficacy, and abuse potential evaluation of cannabinoids and related products.

     

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    The webinar will provide you with an overview and strategies to navigate the development of cannabinoid-based therapies in complex regulatory environments.

    • Learn about the required clinical studies and challenges to testing the efficacy and safety profile of cannabis and cannabinoids to obtain regulatory approval for targeted indications
    • Understand various aspects of clinical trial design relevant to cannabinoids, including route of administration, dosing, subject selection, relevant pharmacodynamic endpoints and safety monitoring
    • Review appropriate bioanalytical methods to monitor plasma levels
    • Learn strategies to navigate the complex US and Canadian regulations around drug scheduling and access to cannabinoid-based investigational drugs for clinical research purposes
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