SupplySide
Premium Series—Dietary Supplement Safety: Understanding the Role of Adverse Event Reports in Product Recalls
Available: On Demand
Posted March 18, 2010 in
Webinar,
Food and Drug Administration (FDA),
Food Safety,
International,
Management Issues
Speakers: Douglas MacKay, N.D., Council for Responsible Nutrition; Rick Kingston, PharmD, SafetyCall International; Patrick Revelle, Director, MedDRA MSSO; James Neal Kababick, Director, Flora Research Labs; Bob Moore, Ph.D., CFSAN, FDA
INSIDER Premium Series
Co-sponsored by
Cost:
CRN Member: $149
Non CRN Member: $199
Objectives: This two hour Webinar will provide attendees with a basic understanding of the role of a corporate postmarket safety surveillance system that includes adverse event reporting to meet mandatory FDA reporting requirements. The Webinar will address the type and scope of information collected, how it is reviewed and analyzed by companies and FDA and how these factors converge to aid in the determination of when, or if, a product recall is necessary. Attendees will gain new insights on how to both prevent and deal with the prospect of a product recall.
I. Introduction (10 minutes)
- Douglas (Duffy) MacKay, N.D., Council for Responsible Nutrition
II. Postmarket Surveillance: Receiving, Documenting, Analyzing and Regulatory Reporting of Adverse Events (20 minutes)
-Rick Kingston, PharmD, SafetyCall International
Understanding and implementing the key elements of a product postmarket safety surveillance system is critical for companies to determine if their product is meeting the needs of their customers without unintended side effects. If allegations of unintended effects are received, the manufacturer is usually in the best position to determine if they signal an issue that warrants further action which could include anything from reformulation or label changes, to even market withdrawal or a consumer level recall. Companies must also meet regulatory adverse event reporting requirements. Ignoring product stewardship best practices can result in enforcement actions or worse, needless harm to your customers, your brand and your company.
III. MedDRA Overview – A Standardized Terminology (20 minutes)
- Patrick Revelle, Director, MedDRA MSSO
This presentation will provide a brief overview of MedDRA which is a terminology that is commonly used internationally by both industry and regulators for adverse event reporting for drugs, devices, foods, and other regulated products. MedDRA is used to both codify and review and analyze data related to both patent events and product issues.
IV. Heading Off a Product Recall: Approaches to Product Testing Before & After the AER Event (20 minutes)
-James Neal Kababick, Director, Flora Research Labs, Adjunct Professor, Bastyr University Botanical Medicine Department
During an investigation of an adverse event report, companies (and FDA) often perform various tests on suspect products in an attempt to identify the offending constituent(s) or exonerate the product. However, if there is not a clear understanding of the likely contaminant, the analyses performed may yield little information of value. When responding to an AER, it is critical to have a systematic approach to Phytoforensic investigations. This requires more than just the ingredients label and the AER report. Application of a thoughtful and systematic approach will offer the best chance of success in the least amount of time possibly saving thousands of dollars in unnecessary testing. Further, applying this same logic to preemptive screening can help companies respond rapidly to AER’s or even avoid them completely.
V. How Adverse Event Reporting Drives Recalls: FDA’s Perspective (20 minutes)
- Bob Moore, Ph.D., Supervisor, Regulations Implementation Team, Division of Dietary Supplement Programs, CFSAN, FDA
This presentation will present an overview of FDA's general process for reviewing adverse events and reaching conclusions about the apparent safety of a particular dietary supplement. Adverse event reports received are entered in FDA's CAERS database and reviewed by staff medical officers. FDA reviewers evaluate the seriousness of the adverse events and their relationship to the suspected dietary supplement. If the initial review indicates that a specific dietary supplement may present a health risk to consumers, FDA would initiate an in-depth review. This process includes, but is not limited to a literature search and review; requesting additional information from academic institutions, individual experts, and industry; consulting experts inside FDA or, if necessary, outside FDA; and preparing a safety review. The safety review informs Agency policy and compliance staff in their consideration of what action by FDA is necessary to ensure the safety of consumers
VI. Q&A (30 minutes)
Speakers:
Douglas “Duffy” MacKay, N.D., is Vice President, Scientific & Regulatory Affairs for the Council for Responsible Nutrition (CRN). Dr. MacKay is a licensed Naturopathic Doctor and was a co-owner and practitioner in a family-owned New Hampshire complementary and alternative medicine private practice for seven years. In addition to his hands-on experience as a practitioner in the field of integrative medicine, he spent eight years working as a medical consultant for two companies in the dietary supplement industry, including four years as an executive with Nordic Naturals, in charge of clinical research. He previously served as Technical Advisor for Thorne Research. Dr. MacKay has published articles in peer-reviewed journals, and serves on the Editorial Board of two peer-reviewed publications: the clinical journal Alternative Medicine Review and the official publication of the American Association of Naturopathic Physicians, Natural Medicine Journal. Dr. MacKay earned his B.S. in Marine Sciences from the University of California, Santa Cruz and his N.D. from the National College of Naturopathic Medicine in Portland, Oregon. Dr. MacKay is licensed in the state of New Hampshire.
Pat Revelle is the Director of the MedDRA Maintenance and Support Services Organization (MSSO). In this role Mr. Revelle is responsible for maintaining and distributing MedDRA as well as providing the full range of implementation services to the international bio-pharmaceutical industry and international regulators. Mr. Revelle has worked for Northrop Grumman for 28 years in a variety of software development and project management positions.
Robert J. Moore, Ph.D., is Supervisor, Regulations Implementation Team, Division of Dietary Supplements Programs, Office of Nutrition, Labeling and Dietary Supplements in the Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition (CFSAN). He joined FDA in 1994 and has worked primarily on dietary supplement enforcement and policy development activities. Prior to joining FDA, he served in the U.S. Army as a research biochemist at the US Army Medical Research and Development Command laboratories in Natick, Massachusetts and San Antonio, Texas. Dr. Moore received his undergraduate degrees in Animal Nutrition from the State University of New York at Cobleskill and from the University of Missouri. He received his PhD in Animal Science and Nutrition from the Virginia Polytechnic Institute and State University and completed his post-doctoral research at the U.S. Department of Agriculture (USDA) Human Nutrition Research Center in Grand Forks, ND.
*All registration fees are non-refundable.