A discussion of current initiatives for mandatory or voluntary system for supplements, approaches for proper implementation and management.
University of Minnesota
College of Pharmacy
Utah Natural Products Alliance in association with ABC, CHPA and CRN
8:00 am - 5:00 pm
Hubert H. Humphrey Room
UNIVERSITY OF MINNESOTA
The safety of herbs and other dietary supplements is front-page news. While most popular herbs have a wide margin of safety, there is growing pressure to adopt a mandatory adverse event reporting (AER) system to track and confirm safety. When HHS Secretary Thompson announced the proposed ephedra ban, he repeatedly stated his intention to mandate an AER system and several trade associations have promoted and supported this idea as well. Industry can take the initiative to proactively deal with this issue. This seminar will provide a forum to discuss the complex issues related dietary supplement postmarket surveillance, and promote a better understanding of the practical implications in adopting, implementing and managing an effective AER system for your company.
In this one-day seminar, participants will:
• Analyze the current legislative calls for mandatory AERs for dietary supplements.
• Examine the “anatomy” of adverse event reports, its investigation, management and resolution.
• Compare multiple AER systems now in use for both supplements and other consumer products.
• Learn how poison control centers receive and manage AERs for dietary supplements and other products.
• Discuss uses, and misuses, of information obtained from various AER systems.
• Discuss the budgeting and costs to implement an effective AER system.
• Learn about alternative approaches toward establishing a national system for dietary supplement adverse event monitoring.
Who should attend?
• Senior-level management
• Corporate scientists
• In-house counsel & regulatory managers
• Insurance and risk managers
• Quality assurance (QA) and quality control (QC) staff
• Marketing and sales staff