The Highs and Lows of Cannabinoid Research: Exploring the Regulatory, Clinical, and Bioanalytical Requirements in US and Canada, New Webinar Hosted by Xtalks

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.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food, and medical device community. Every year thousands of industry practitioners (from life science, food, and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends, and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com

For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar

Contact:

Nima Rajan

Tel: +1 (416) 977-6555 ext 352

Email: nrajan@xtalks.com

Source : Xtalks
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