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Dietary Supplement Adverse Event Reporting—a 10-Year Perspective and Review

Event Date: Wednesday, Nov 15, 2017 02:00 PM EST

Test your system first before registering for this event.

It's more important than ever that companies understand how FDA and the public view adverse event reports (AERs) and that they have a sophisticated system in place to monitor, report, follow up, and maintain consumer complaints and adverse events. On December 22, 2006, the Dietary Supplement and Nonprescription Drug Consumer Protection Act was signed into law. This law amended the Federal Food Drug & Cosmetic Act to require supplement companies to report serious adverse events to FDA within 15 days of receiving the report, and to keep records of non-serious adverse events for six years. Although the law has been in effect for nearly 10 years and remains unchanged, the industry still faces challenges with regard to how AERs are perceived and interpreted.

CRN embraced FDA's decision in December 2016 to make public data from FDA's Center for Food Safety and Applied Nutrition's (CFSAN) Adverse Event Reporting System (CAERS), calling it a demonstration of the agency's commitment to transparency. However, the public availability of this data could increase a company's risk of litigation if the data isn't properly interpreted or put into context. In addition, a recent study in the Journal of Medical Toxicology misinterpreted poison control center data, providing an inaccurate picture of dietary supplement safety. This webinar will help participants navigate AERs with expert insights on key topics.

  • Receive a brief overview of the AER law and the requirements for dietary supplement businesses
  • Hear FDA's perspective on AER compliance and response
  • Gain a better understanding of FDA's increased attention to transparency and industry's response
  • Learn about the impact of poison control center data in context of AERs
  • Receive practical advice and considerations for in-house AER compliance systems

Register for this webinar for an opportunity to ask additional questions.

Moderator:

Rend Al-Mondhiry, Esq. Rend Al-Mondhiry, Esq.
Associate General Counsel, Counsel For Responsible Nutrition (CRN)

Ms. Al-Mondhiry provides legal counsel and advice to CRN's staff and members in the areas of legislation, regulatory compliance and advocacy, and international policy development with respect to dietary supplements and nutrition issues. She also advises the association on a variety of general business matters, including contract drafting, negotiation and review, non-profit and association governance issues, and general corporate matters affecting CRN, CRN-International, and the CRN Foundation Healthcare Products Association (CHPA) where she provided testimony and comments on legislative and regulatory proposals. Previously, Ms. Al-Mondhiry worked as state legislative counsel for the Consumer, drafted legislation and regulatory language and served as a policy expert in the area of food and drug law. Prior to joining CHPA, she worked at the American Speech-Language-Hearing Association, serving as the director of state legislative and regulatory advocacy. Ms. Al-Mondhiry received her BA from The George Washington University and her JD from Pennsylvania State University, Dickinson School of Law.

Speakers:

Lyle Canida Lyle Canida
Branch Chief, Center for Food Safety and Applied Nutrition (CFSAN)

LCDR Lyle Canida is the Branch Chief for the Signals Management Branch in the Office of Analytics and Outreach at FDA's Center for Food Safety and Applied Nutrition (CFSAN). He is a Commissioned Corps officer with a Doctor of Pharmacy, a Master of Science in pharmacoepidemiology, and is Certified in Public Health. He previously worked in the Office of Surveillance and Epidemiology as a safety regulatory project manager, and prior to that in the Office of Clinical Pharmacology at the Center for Drug Evaluation and Research as a pharmacogenomics reviewer for new drug applications.

Rick Kingston PharmD Rick Kingston, PharmD.
President, Regulatory & Scientific Affairs/Sr. Clinical Toxicologist, SafetyCall International P.L.L.C.

Dr. Rick Kingston is the President, Regulatory and Scientific Affairs at SafetyCall International P.L.L.C., a multidisciplinary healthcare firm academically affiliated with the University of Minnesota. The firm is focused on providing consumer product manufacturers' services in the area of post-market medical surveillance, product safety review, and regulatory reporting support for adverse events. His academic career spans more than 30 years at the University of Minnesota where he attained the rank of full Professor in the Department of Experimental and Clinical Pharmacology and currently serves as Clinical Professor, in the College of Pharmacy. He is also an Adjunct Professor at the University of Mississippi, College of Pharmacy and National Center for Natural Product Research (NCNPR). He was the co-founder of the Minnesota Poison Control System and its Regional Poison Control Center where he served for 18 years. He has published and presented extensively in the field of clinical toxicology, and serves on numerous scientific panels, advisory boards and non-profit professional organization scientific committees advising on issues of product stewardship, science and safety. His professional expertise spans the areas of consumer product post-market surveillance and safety assessment, natural product toxicology, clinical toxicology and pharmacology, injury prevention, poison control, and toxicology related regulatory policy.

Jessica P. O'Connell Michelle Jackson
Partner, Venable LLP

Ms. Jackson's practice is focused on regulatory counseling concerning the development, formulation, manufacture, distribution, and promotion of FDA-regulated products, with a focus on dietary supplements. She handles matters involving regulation and enforcement by federal and state agencies, including the U.S. Food and Drug Administration (FDA), the U.S. Federal Trade Commission (FTC), and state Attorneys General. Ms. Jackson routinely advises clients on handling adverse events, from drafting and implementing Standard Operating Procedures (SOPs) to evaluating whether a particular adverse event must be reported to the FDA. In the event of agency enforcement actions, Ms. Jackson helps clients respond to inspectional observations (form 483), Warning Letters from the FDA, civil investigative demands (CIDs) from the FTC, and subpoenas from state Attorneys General. Ms. Jackson also understands the risks of potential plaintiff lawsuits (including class actions), and she advises clients on ways to help lower their risks.

Christina Romano Christina Romano
Product Vigilance Manager, The Nature's Bounty Co.

Christina Romano MS, BSN, RN is the Product Vigilance Manager at The Nature's Bounty Co. Ms. Romano leads the Product Vigilance Team in adverse event reporting, post market surveillance activities and product lifecycle contributions for The Nature's Bounty Co.'s products. With the enactment of the adverse event reporting law (DSNDCP Act) in the U.S., the company constructed an internal framework for adverse event reporting (AER) and comprehensive compliance processes from the ground up. Ms. Romano was instrumental in developing and implementing this robust AER compliance system based on best practice pharmacovigilance principles. Ms. Romano has held various clinical nursing leadership positions in surgical services and developed patient programs integrating complementary and alternative medicine. In these roles, her regulatory responsibilities included safety and compliance of medical devices, pharmaceuticals and herbal/essential oil extracts, sentinel event handling, and regulatory agency compliance and inspections. Additionally, Ms. Romano's educational background includes organizational leadership, product safety and innovation, and public health.