Event Overview:
Many experts have discussed the Federal Trade Commission’s Health Products Compliance Guidance over the year since its release. Two more experts have come together for the first time to infer beyond what the guidance states. One speaker, who has spent a lifetime in claim substantiation using clinical trials, and another a legal beacon for advertising compliance, will dissect the guidance as well as share more compliance tips in this not-to-be missed webinar. This is compliance made easy.
Key Learning Objectives
- Systematically slice up what the FTC says, and does not say, (but nevertheless useful) to improve clinical trial compliance to support your advertising claims
- Understand various compliance tips for designing, conducting, reporting and using of clinical studies to meet FTC’s advertising standards for dietary supplements and other products making health claims
- Engage in a live Q&A with the experienced speakers, addressing specific concerns and queries
Who Should Attend
- Clinical Trials
- Regulatory
- R&D
- Marketing
- Legal
- Top Management
Speakers:
Jayesh Chaudhary
CEO/Founder
Vedic Lifesciences
Jayesh Chaudhary, a veteran of the nutraceutical industry, has dedicated the 30 years of his career to developing and commercializing proven natural ingredients and products. He is co-founder of Enovate Biolife, a leading nutraceutical ingredients company from India and Vedic Lifesciences, a Contract Research Organization (CRO) dedicated to Food Supplement Research. Enovate Biolife are makers of clinically proven and patented sports nutrition, heart health, joint health, and other active ingredients for lifestyle and wellness products in markets such as the US, Canada, EU, Japan, and South Korea. Vedic Lifesciences has conducted more than 400 preclinical and clinical studies on dietary supplements and herbal products for clients across the globe. Vedic is one of the top food supplement CROs globally serving industry leaders like ADM, Lonza, Kerry, Novozymes, Chr. Hansen, Kemin, Bioiberica, OmniActives, Fuji Chemicals, Gaia Herbs, DSM, etc. Both companies have been recognized for their innovative work by industry awards consistently in all key regions.
One of the pioneers to bring Good Clinical Practice and other stringent standards to natural product research, Jayesh is alumni of KMK College of Pharmacy, Mumbai and the University of Minnesota, Twin Cities, US. He has co-authored numerous articles and papers on trends in the nutra-industry and continues to be a thought leader in nutraceutical clinical development. Jayesh leads a team of physicians, pharmacists, and scientists from various disciplines. Prior to this role, Jayesh has held positions in pharma/biotech in India.
Todd A. Harrison
Partner
Venable LLP
Todd Harrison, co-chair of Venable’s FDA Group has substantial experience in food and dietary supplement marketing, including health claims, structure/function claims, and nutrient content claims. He is also well versed in federal, state, and international consumer protection agency rules related to drugs, food, supplements, homeopathic remedies, medical devices, and cosmetics. He concentrates on compliance and cooperation with the Food and Drug Administration (FDA), the Department of Agriculture’s Food Safety and Inspection Service (FSIS), the Animal and Plant Health Inspection Service (APHIS), the Agricultural Marketing Service (AMS), the FTC, and the Drug Enforcement Administration (DEA).
Todd advises clients on labeling requirements, organic products, and genetically modified organisms — developing strategies for companies to communicate information about their products without running afoul of agency regulatory requirements. He has assisted companies with compliance issues, including Hazard Analysis and Critical Control Points (HAACP), best practices in manufacturing, product recalls versus market withdrawals, inspections, warning letters, FDA and the FSIS standards of identities compliance, importing meat and poultry products into the United States, and recordkeeping.
Todd drafts opinion letters regarding the status of food ingredients in the United States and assists in the preparation of food additive petitions, Generally Recognized as Safe (GRAS) notifications, and new dietary ingredient notifications. He also helps companies develop self-determined GRAS positions for food ingredients.
Register Free: https://www.nutritionaloutlook.com/no/clinical-trial-planning
