Conducting a clinical trial in the health nutrition industry can be an intimidating process. In an extremely competitive market, the company and the products must be able to withstand the heightened scrutiny that accompanies the industry. Clinical trials can be the greatest investment or a regulatory nightmare. To set your clinical trial up for success, there are key factors that need to be addressed. Having the right study design offers your trial the best chance to achieve statistical significance. Without significance, you don’t have the support to substantiate your structure/function claims or health claims. Our newest
seminar will cover the regulatory requirements from the Food and Drug Administration (FDA) and Federal Trade Commission (FTC), focusing on the FTC’s new stance on Randomized Clinical Trials (RCTs) as well as EFSA and Health Canada regulation. Learn the ins and outs of requirements on claims prior to putting your product on the market.
You will learn from our experts about how to identify and establish appropriate study endpoints and goals to yield substantiation for your product claims. In addition, you will hear about common misconceptions within the industry that could be setting up your trials for failure, or worse, leading you to regulatory vulnerability. Cost: $595-$995. Separate Registration Required.
Click here for more information and to register.