Subjects: TRI, FDA, MAT
How to Reduce Your Regulatory Risk in the Renaissance of Hemp-Derived "Ceutical" Products, Upcoming Webinar Hosted by Xtalks
TORONTO, Sept. 11, 2019 /PRNewswire-PRWeb/ -- With recent regulatory changes to state and national laws, cannabis is undergoing a period of rediscovery and attraction from big pharma, nutraceutical manufacturers, food companies, and retailers.
Chronic CBD users represent 7 percent of the American population, and North American use rates are expected to rise as access to hemp-derived CBD food products increases. In preclinical studies, CBD shows potential therapeutic efficacy against a diverse array of clinical conditions, yet there are major research gaps in our understanding of CBD efficacy for most medical conditions touted in marketing.
Food and dietary supplement contract manufacturers and own label distributors are responsible for knowing the No Observed Adverse Effect Level (NOAEL) which can be learned from clinical studies of the test article. The road to regulatory approval by regulators such as the US Food and Drug Administration (FDA) and Health Canada features safety assessments from preclinical rodent testing, clinical trials, New Dietary Ingredient notifications (NDINs), licensing agreements and more.
In this free webinar, experts from KGK Science will help regulatory personnel, senior level executives, contract manufacturers and food toxicologists navigate this complicated process. The live session with Chief Science Officer Mal Evans, DVM, PhD and Chief Regulatory Officer Corey Hilmas, MD, PhD will take place on Wednesday, September 25, 2019 at 1pm EDT. The presentation will be followed by a live Q&A period.
Specific learning objectives include:
- CBD research and ideas to substantiate claims for your board room discussion
- Critical safety components in clinical trials for CBD essential oil for FDA regulators
- How to reduce your regulatory risk with food safety dossiers
- How to craft sufficiently qualified, limited-in-scope structure function claims
- Creating non-disease endpoints in clinical trials for substantiating structure function claims
- How FDA evaluates dietary ingredient and supplement product safety from a former federal regulator
- FDA and FTC requirements to meet compliance
- Best-in-class practices adopted by large corporations to manage risk
For more information or to register for this free event, visit How to Reduce Your Regulatory Risk in the Renaissance of Hemp-Derived "Ceutical" Products.
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 and 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/
SOURCE Xtalks
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