Adverse Event Reporting (AER) and Dietary Supplements: Challenges & Opportunities
A discussion of current legislative calls for mandatory AER for dietary supplements, methods for proper implementation and risk management.
Attendance restricted to first 300 registered individuals
This forum is sponsored by UNPA (Utah Natural Products Alliance) and ABC (American Botanical Council)
February 20, 2004
Huntsman Cancer Institute
Salt Lake City, Utah
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 to understanding AER, provide a framework for AER documentation, and highlight existing and emerging safety information programs designed to help companies promote responsible use of supplements and help prevent AERs.
In this one-day seminar, participants will:
• Analyze the current legislative calls for mandatory AERs for dietary supplements.
• Examine the AER system laid out in the Food & Drug Administration’s proposed GMP regulation for dietary supplements.
• Compare AER systems now in use for supplements.
• Learn how poison control centers receive and manage AERs for dietary supplements.
• Learn about the American Botanical Council’s Safety Labeling Program and how providing more safety information can prevent AERs and reduce legal risks.
• Discuss the budgeting and costs to implement an effective AER system.
Who should attend?
• Senior-level management
• In-house counsel & regulatory managers
• Insurance and risk managers
• Quality assurance (QA) and quality control (QC) staff
• Marketing and sales staff
Attn: Lindsay Wright, Utah Natural Products Alliance (UNPA)
1075 Hollywood Avenue, Salt Lake City, UT 84105
Tel: (801) 474-2572 / Fax: (801) 474-2571 / e-mail: [email protected]