Press Release (ePRNews.com) - TORONTO - Jun 21, 2018 - 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.
This live webinar upcoming on Wednesday, July 11, 2018, at 10 a.m. EDT (3 p.m. BST/UK), will provide you with an overview and strategies to navigate the development of cannabinoid-based therapies in complex regulatory environments.
Join industry experts from Syneos Health Dr. Talar Hopyan, Associate Director of Scientific Affairs-Neuropsychology, Dr. Beatrice Setnik, Vice President of Scientific and Clinical Strategy and Sylvain Lachance, Associate Director of Bioanalysis to gain the following insights:
- 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 the 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
For more information about this complimentary webinar visit: The Highs and Lows of Cannabinoid Research: Exploring the Regulatory, Clinical, and Bioanalytical Requirements in US and Canada.
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