Kevin M. Bell Spoke on Clinical Trial Regulation During Webinar
Kevin M. Bell, Principal at Porzio, Bromberg & Newman, participated in a webinar on, "Avoiding a Regulatory Nightmare: Study Endpoints and Claim Substantiation for Clinical Trials." The webinar, presented by Natural Products Association, took place on Wednesday, January 28, 2015 from 2:00pm - 3:30pm (EST).
The webinar, featured Bibiane Zakaria, Director of Sales and Client Services at KGK Synergize Inc., Kevin Bell, Principal at Porzio, Bromberg & Newman R.C., and Corey Hilmas, M.D., Ph.D., Senior Vice President of Scientific & Regulatory Affairs at NPA.
Areas of discussion included:
- How to produce successful clinical trials
- Importance of defining goals (i.e., marketing and claims substantiation) prior to starting the research process
- What factors to consider when developing a clinical trial
- High-profile regulatory cases on claim substantiation for dietary supplements
- The scary aftermath of 2014 regarding substantiation and what the industry can expect moving into 2015
- Myth Debunking: Redefining the allowable claims in the U.S. and Europe in comparison to Canada
- Meeting U.S. and Canada requirements for clinical trials
- Choosing the right study endpoint
- How to translate structure/function claims to endpoints in clinical trials
- A discussion of structure function endpoints in hypothesis driven clinical research
- How to declaim the disease origins of a claim, limit its scope, and test in a clinical trial
For more information regarding the webinar or to register, please visit the Natural Products Association website.